20 Clinical Fellowship jobs in Saudi Arabia
Mgr Clinical Research
Posted today
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Job Description
Job Purpose / Summary
Responsible for staffing and managing Employee, Consultant or Freelance Clinical Research Associates (CRAs), In-House Clinical Research Associates (, Clinical Project Assistants (CPAs) and Clinical Projects Coordinators (CPCs) and ensuring adherence to and implementation of CTI policies. Manage quality and consistency of CRA services across multiple projects according to all applicable regulatory guidelines, Good Clinical Practices (GCPs) and Standard Operating Procedures (SOPs). 
Essential Functions
- Responsible for the ongoing job specific training and mentoring of the subordinate CRAs and CPAs/CPCs s in accordance with Department goals and mission.  Supervision of the work of subordinate CRAs and CPAs/CPCs.
- First line of communication and escalation for the subordinate CRAs and CPAs/CPCs, including for HR and administrative issues.
- Issue, Task and Time management of the subordinate CRAs and CPAs/CPCs.
- Assuring compliance of subordinate CRAs and CPAs/CPCs to the applicable procedures, guidelines, timelines, and deliverables.
- Regular assessments and appraisals of CRAs and CPAs/CPCs and their level of competence.
- Quality Control - performs co-monitoring visits and reviews visit reports for the subordinate CRAs when needed.
- Regular reporting to Director CLO Dept. and participation in meetings with other CRMs, PMs.  Participate in the process of development and update of department-specific company SOPs and Wis when required
- Execute any activities in compliance with applicable SOPs, instructions and principles.
- Provide enough/trained resources for all projects to ensure smooth conduction of study specific activities.
- Collaborate with Director of clinical operations , on planning, assigning, and directing billable work assignments to CRAs, to ensure projects are properly resourced and study timelines are met.
- Assist in collecting preliminary and follow-up information from clients, with the purpose of identifying and evaluating project feasibility pertaining to clinical monitoring.
- Assist with defining operational Key Performance Indicators and departmental goals.
- Manage recruitment process for CRAs (and Consultant/Freelance CRAs as applicable), including review of CVs and conducting interviews collaboratively with Human Resources and others.
- Collaborate with other functional areas within CTI to ensure CRA (and Consultant/Freelance CRA as applicable) on-boarding, off-boarding, and project handovers are effective and timely
What You'll Bring:
- 2-3 years clinical research monitoring experience
- Practical experience in conducting clinical studies with pharmaceutical company or Contract Research Organization (CRO)
- Bachelor's degree in allied health fields such as nursing, pharmacy, or health science or equivalent experience as determined by CTI Management and Human Resources
About CTI
CTI Clinical Trial and Consulting Services is a global, privately held, full-service clinical contract research organization (CRO) focused on the advancement of treatments for chronically and critically ill patient populations. We assist clinical research throughout the lifecycle of development, from drug concept to commercialization. CTI is headquartered in the Greater Cincinnati, OH region with global operations in collaboration with pharmaceutical, biotechnology, and medical device firms. For more information, visit  
Why CTI?
At CTI, we recognize that our people are what make our company successful. Our work moves medicine forward. 
- Advance Your Career - We support career progression through a structured mentoring program and leadership courses that provide the support needed to grow. We also value ongoing education and training through a dedicated training department.
- Join an Award-Winning and Valued Team - We have an award-winning unparalleled culture that can be felt by our employees across 60 countries. We support a work-life balance and the importance of time with family by offering hybrid work from home opportunities. We also encourage care for the world around us through our unique CTI Cares program.
- Make a Lasting Impact - We focus on moving medicine forward by working on treatments for chronically and critically-ill patients, who depend on us to bring life-changing therapies to market.
Important Note
In light of recent increase in hiring scams, if you're selected to move onto the next phase of our hiring process, a member of our team will reach out to you directly from  email address to guide you through our interview process. Please ensure you are applying for jobs directly on our website
)
or from our verified LinkedIn page. 
Please Note
- We will never communicate with you via Microsoft Teams or text message
- We will never ask for your bank account information at any point during the recruitment process
Clinical Research Coordinator
Posted today
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Job Description
Company Description
ClinLia is a Saudi Clinical Research Organization (CRO) with extensive experience in clinical research support and management services. We operate across a broad range of therapeutic areas to align with the new vision of Saudi Arabia 2030. Our goal is to advance clinical research and innovations to position the Kingdom on the clinical trials map.
Role Description
This is a full-time, on-site role located in Riyadh for a Clinical Research Coordinator/Laboratory Qualified. The Coordinator will be responsible for overseeing day-to-day clinical research activities, obtaining informed consent from participants, ensuring adherence to protocols, and managing clinical trials. Additional duties include handling laboratory tasks, conducting research, and ensuring compliance with regulatory requirements.
Qualifications
- Experience with Informed Consent and Protocol adherence
- Background in Research and Clinical Research Experience
- Experience managing Clinical Trials
- Excellent organizational and communication skills
- Ability to work on-site in Riyadh
- Bachelor's degree in a related field (e.g., life sciences, healthcare)
- Previous experience in a laboratory setting is a plus
Clinical Research Associate
Posted today
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Job Description
Clinical Research Associate (level dependent on experience)
Job Purpose/Summary
As a CRA you will be responsible for the successful conduct of clinical trials and serve as the main contact for the investigative site by representing CTI in a professional manner.
What You'll Do
- Conduct evaluation, initiation, monitoring and close out visits
- Assist with regulatory and study start-up activities including contract and budget negotiations
- Ensure clinical data integrity and meet study timelines
- Provide ongoing updates and support to project management
- Attend global project meetings including investigator meetings and global team teleconferences
- Complete assigned training programs in drug development processes, therapeutic areas, Good Clinical Practices (GCPs) and any applicable local regulatory requirements.
What You Bring
- 2 - 3 years of clinical research experience as a CRA or related profession
- Life science background
- Excellent knowledge in ICH-GCP and regulatory requirement
- Fluent in English
Why CTI?
At CTI, we recognize that our people are what make our company successful. Our work moves medicine forward.
For that reason, we treat our team members with the respect they deserve, and our numbers show it:
- We support career progression – We believe in promoting from within and we have a structured mentoring program and program for recent graduates to provide the support employees need to move forward
- We value education and training – We provide tuition assistance, partner with universities and colleges to create programs in our field, and have a dedicated training department
- We value our people - We have never had a layoff in our three decade history and we guaranteed full pay for our employees during the COVID-19 shut-down regardless of the number of hours worked. We support a work-life balance and the importance of time with family by offering generous vacation time, a hybrid work from home schedule, and paid parental leave.
- Our culture is unparalleled – We've received multiple awards recognizing CTI as one of the best places to work in the greater Cincinnati area, as well as one of the top CROs in the industry
- We think globally and act locally – With employees across 60 countries, we have global reach but maintain culture and connections to the local communities in which we work. Our CTI Cares Committees are dedicated to ensuring the CTI culture and values translate around the world.
- We are looking toward the future – We have had a consistent double-digit growth rate over the last decade, invest in cutting-edge technology, and pride ourselves on our average annual retention rate of 95%, which is much higher than many other CROs
- Our work makes a difference – We focus our work on treatments for chronically and critically-ill patients, who are depending on us to bring these life-changing therapies to market
Are you interested? Then we look forward to your electronic application, with a tabular CV in English.
CTI Clinical Trial and Consulting Services
Filipa Magalhães
Clinical Research Associate I
Posted today
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Job Description
JOB PURPOSE / SUMMARY
Responsible for project activities associated with monitoring functions of phase I through phase IV clinical research studies and Real World Evidence (RWE) studies, while developing an understanding of drug development process, International Council for Harmonisation (ICH) / Good Clinical Practice (GCP) and relevant regulations. Performs management of study site activities in adherence to all applicable regulatory guidelines and Standard Operating Procedures (SOPs).
ESSENTIAL FUNCTIONS
- Serve as main CTI contact for assigned study sites
- Conduct site visits (pre-study (PSV), site initiation (SIV), interim monitoring (IMV), and close-out (COV)) and complete site visit deliverables with quality and within given timelines in Monitoring Plan while adhering to all applicable regulatory requirements, SOPs and ICH GCP 
- Assist with study start-up activities, including feasibility, pre-study activities and site selection 
- Collect, review and track essential/regulatory documents
- Participate in and complete all general and study specific training as required
- Participate in investigator, client and project team meetings
- Assist in developing patient enrollment strategies with Project Team and study sites
- Ensure proper storage, dispensation and accountability of all Investigational Product (IP) and trial-related materials
- Perform site management activities and provide ongoing updates of site status to Clinical Project Manager
- Conduct remote monitoring and complete all the related activities in accordance with study specific Monitoring Plan
- Utilize systems and reports to track subject status, subject case report form (CRF) retrieval / source document review (SDV), regulatory documents, and IP
- Assist with project-specific activities as member of Project Team
- May support in development of CRFs and other study related documents (subject worksheets, Monitoring Plan, etc.
- May support in the translation, customization, and review of Patient Information sheet and Informed Consent, protocol synopsis and other study applicable documents as per required procedures
- Where applicable, provide support to Regulatory Affairs Study Start-up Team in the preparation or revision of documentation for submission to Ethics Committee(s), Institutions Ethics Committees, Regulatory Authorities, Competent Authorities or Institutions Administration Boards, and follow-up the evaluation process until approval is available.
- Provide regular updates to Sponsor/ Client
- Where applicable, support in contract negotiation with study sites, Investigator payments and tracking of site payments
- Manage ISF and TMF for all assigned study sites in accordance with SOPs or study-specific Monitoring Plans
- Identify site issues and implement corrective actions or escalate as appropriate
- Liaise with Clinical Data Management for data cleaning activities
What You'll Bring:
- At least 2 years of clinical nursing experience, or at least 1 year of experience in related health care or clinical research work experience (ONCOLOGY) (ie, Study Coordinator), or at least 1 year experience performing relevant project support in-house functions 
- Bachelor's Degree or higher in allied health field such as nursing, pharmacy, or health / natural science, or RN with Associate's Degree, or 3-year Nursing Diploma with at least 2 years clinical nursing experience, or equivalent experience as determined by CTI Management and Human Resources 
About CTI
CTI Clinical Trial and Consulting Services is a global, privately held, full-service clinical contract research organization (CRO) focused on the advancement of treatments for chronically and critically ill patient populations. We assist clinical research throughout the lifecycle of development, from drug concept to commercialization. CTI is headquartered in the Greater Cincinnati, OH region with global operations in collaboration with pharmaceutical, biotechnology, and medical device firms. For more information, visit
Why CTI?
At CTI, we recognize that our people are what make our company successful. Our work moves medicine forward.
- Advance Your Career - We support career progression through a structured mentoring program and leadership courses that provide the support needed to grow. We also value ongoing education and training through a dedicated training department.
- Join an Award-Winning and Valued Team - We have an award-winning unparalleled culture that can be felt by our employees across 60 countries. We support a work-life balance and the importance of time with family by offering hybrid work from home opportunities. We also encourage care for the world around us through our unique CTI Cares program.
- Make a Lasting Impact - We focus on moving medicine forward by working on treatments for chronically and critically-ill patients, who depend on us to bring life-changing therapies to market.
Important Note
In light of recent increase in hiring scams, if you're selected to move onto the next phase of our hiring process, a member of our team will reach out to you directly from  email address to guide you through our interview process. Please ensure you are applying for jobs directly on our website
)
or from our verified LinkedIn page. 
Please Note
- We will never communicate with you via Microsoft Teams or text message
 
- We will never ask for your bank account information at any point during the recruitment process
Clinical Research Associate I
Posted today
Job Viewed
Job Description
Serve as main CTI contact for assigned study sites
- Conduct site visits (pre-study (PSV), site initiation (SIV), interim monitoring (IMV), and close-out (COV)) and complete site visit deliverables with quality and within given timelines in Monitoring Plan while adhering to all applicable regulatory requirements, SOPs and ICH GCP 
- Assist with study start-up activities, including feasibility, pre-study activities and site selection 
- Collect, review and track essential/regulatory documents
- Participate in and complete all general and study specific training as required
- Participate in investigator, client and project team meetings
- Assist in developing patient enrollment strategies with Project Team and study sites
- Ensure proper storage, dispensation and accountability of all Investigational Product (IP) and trial-related materials
- Perform site management activities and provide ongoing updates of site status to Clinical Project Manager
- Conduct remote monitoring and complete all the related activities in accordance with study specific Monitoring Plan
- Utilize systems and reports to track subject status, subject case report form (CRF) retrieval / source document review (SDV), regulatory documents, and IP
- Assist with project-specific activities as member of Project Team
- May support in development of CRFs and other study related documents (subject worksheets, Monitoring Plan, etc.
- May support in the translation, customization, and review of Patient Information sheet and Informed Consent, protocol synopsis and other study applicable documents as per required procedures
- Where applicable, provide support to Regulatory Affairs Study Start-up Team in the preparation or revision of documentation for submission to Ethics Committee(s), Institutions Ethics Committees, Regulatory Authorities, Competent Authorities or Institutions Administration Boards, and follow-up the evaluation process until approval is available.
- Provide regular updates to Sponsor/ Client
- Where applicable, support in contract negotiation with study sites, Investigator payments and tracking of site payments
- Manage ISF and TMF for all assigned study sites in accordance with SOPs or study-specific Monitoring Plans
- Identify site issues and implement corrective actions or escalate as appropriate
- Liaise with Clinical Data Management for data cleaning activities
- At least 2 years of clinical nursing experience, or at least 1 year of experience in related health care or clinical research work experience (ONCOLOGY) (ie, Study Coordinator), or at least 1 year experience performing relevant project support in-house functions 
- Bachelor's Degree or higher in allied health field such as nursing, pharmacy, or health / natural science, or RN with Associate's Degree, or 3-year Nursing Diploma with at least 2 years clinical nursing experience, or equivalent experience as determined by CTI Management and Human Resources 
Senior clinical research Associate
Posted today
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Job Description
Job Title: Senior Clinical Research Associate (CRA)
Location: Riyadh, KSA
Job Type: Full-time 
Job Description
We are seeking a highly motivated Senior CRA to join our team on behalf of a leading multinational organization. The selected candidate will be responsible for overseeing and managing clinical trials from initiation to close-out, ensuring compliance with protocols, regulatory requirements, and SOPs.
Key Responsibilities:
- Oversee and coordinate clinical trial activities including investigator selection, patient recruitment analysis, and preparation of study-related documentation (protocols, CRFs, IBs, informed consents, agreements).
- Prepare and manage regulatory submissions and follow-up to ensure timely approvals.
- Organize and conduct investigator start-up meetings and site initiation visits.
- Ensure proper drug accountability at assigned clinical sites.
- Verify CRF data entries against source documentation.
- Ensure timely reporting and follow-up of all adverse events in accordance with protocol and applicable guidelines.
- Monitor trial activities in line with the protocol, monitoring plan, and SOPs.
- Plan, order, and manage clinical trial materials (CTMs) from sponsors.
- Maintain accurate and up-to-date Trial Master Files (TMFs) in compliance with local, legal, and ethical standards.
- Track completed CRFs and ensure timely transfer to data management.
- Maintain essential project files including EC approvals, CVs, IBs, protocols, consent forms, lab ranges, and correspondence.
- Deliver study-specific training to site staff and ensure effective ongoing communication.
- Escalate quality concerns to the Clinical Operations Manager (COM) and ensure corrective measures are implemented.
- Document site management activities, monitoring visit findings, and follow-up actions through detailed reports.
- Support patient recruitment strategies via investigator engagement, newsletters, and awareness initiatives.
- Collaborate closely with the COM and assume delegated responsibilities when required.
- Supervise and mentor CRAs and clinical trial assistants, providing guidance and training as needed.
- Report any instances of GCP non-compliance, misconduct, or fraud appropriately.
- Actively participate in departmental planning and contribute to continuous process improvement.
Qualifications:
- Education: Degree in Pharmacy or Medicine.
- Experience: Minimum of 2 years in clinical research.
- Residency: Based in Riyadh, KSA.
Job Type: Full-time
Experienced Clinical Research Associate Sponsor-dedicated
Posted today
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Job Description
Experienced Clinical Research Associate Sponsor-dedicated page is loaded Experienced Clinical Research Associate Sponsor-dedicated Apply locations Riyadh, Saudi Arabia time type Full time posted on Posted Yesterday job requisition id R
 Job Overview  
 Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.  
 Essential Functions  
• Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and Good Clinical Practice. 
• Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability. 
• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues. 
• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate. 
• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase. 
• Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements. 
• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation. 
• Collaborate and liaise with study team members for project execution support as appropriate. 
• If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis. 
• If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.  
 Qualifications  
• High School Diploma or equivalent Degree in scientific discipline or health care preferred. 
• Requires at least 2 years of year of on-site monitoring experience. 
• Equivalent combination of education, training and experience may be accepted in lieu of degree. 
• Good knowledge of, and skill in applying, applicable clinical research regulatory requirements. 
• i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines. 
• Good therapeutic and protocol knowledge as provided in company training. 
• Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable). 
• Written and verbal communication skills including good command of Arabic and English language. 
• Organizational and problem-solving skills. 
• Effective time and financial management skills. 
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.  
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide . Learn more at
Similar Jobs (1) Experienced Clinical Trial Assistant locations Riyadh, Saudi Arabia time type Full time posted on Posted Yesterday #J-18808-LjbffrBe The First To Know
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Country Lead Associate Director Clinical Research
Posted today
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Job Description
This role combines the accountability of a clinical research manager and certain elements of a GCTO country lead role. Holders of this position are accountable for 
- The performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, Our company's policies and procedures, quality standards and adverse event reporting requirements internally and externally
- Under the oversight of the CRD, providing leadership to a country liaising with local country Management team, participating in the local medical governance and providing oversight for the GCTO team in the country serving as a primary point of contact for managing clinical trial execution in all its aspects across phases I/II through III/IV in that country It could include line management of the GCTO our company's employees if required
Responsibilities include, but are not limited to
CRM component ( Minimum of 50% of time expected to be project related, to be defined according to the need)
- Point of Contact (POC) for assigned protocols between Country Operations (CO) and clinical trial team (CTT) ( or ROC where applicable)
- Pro-actively drives/tracks execution and performance of deliverables/timelines/results to meet country commitments for assigned protocols. Strong collaboration with local CO roles. Forecasts country resource needs. Serves local business needs (signs contracts, manages budgets as delegated).
- Responsible for quality and compliance in assigned protocols in country in close collaboration with CRAs and local study team. Reviews Monitoring Visits Reports and Escalates performance issues and training needs to CRA manager and/or functional vendor and internal management as needed.
- Responsible for collaboration with functional outsourcing vendors, investigators, other external partners. Oversees country and site validations, site selection and recruitment in assigned protocols. Responsible for clinical trial education to sites. Country POC for programmatically outsourced trials for assigned protocols.
- Collaborates internally with local PV, Regulatory, GMA/GHH to align on key decisions in his/her studies. Significantly impacts on the ability to effectively conduct clinical studies and develop the pipeline, while maintaining local regulatory and compliance requirements in countries. The position has a significant impact on how a country can deliver country-specific trial commitments and objectives. As a customer-facing role, this position will build business relationships and represent our company's with investigators, functional outsourcing partners and other external partners and therefore have a significant impact on country-level customer relationships.
- Oversee country commitments, compliance and training needs. Additionally, business leadership and alignment with corporate requires that individual has ability to lead across several dimensions simultaneously.
- Works collaboratively with Country, Regional and HQ Operations; Pharmacovigilance, Regulatory, Global Medical Affairs and Global Human Health internally; and with external functional outsourcing vendors. Requires coordination and alignment with the regional and broader organization. Additionally, will work to build and maintain relationships with investigators and other external partners and promote the company reputation. In collaboration with CRD and/or CRM manager represents our company's in Pharma industry issues and in seeking influence in external R&D environment.)
Country Lead component (% of time to be defined according to the needand always less than 50% or less than 25% if no line management is included.)
- Work collaboratively in a matrix organization with all groups within GCTO, especially with Clinical Sciences and Study Management (CSSM), Clinical Quality Managers (CQMs), to deliver objectives.
- Collaborate with Functional Service Provider (FSP) local Leadership to ensure adequate and appropriate resourcing for the Our company's internal clinical trial portfolio
- Collaborate with Clinical Research Organization (CRO) local Leadership to ensure the successful implementation of fully-outsourced clinical trials
- Represents GCTOin the Medical Governace council.
- Support the development and management of Investigator relationships in conjunction with the OUR RESEARCH & DEVELOPMENT DIVISION Therapy Areas, and when appropriate, Human Health colleagues. Contribute to the program life-cycle management through effective study allocation and execution (prioritizing programs, working with KOLs, etc.).
- Take responsibility for any subsidiary clinical audits, working closely with the Quality Assurance (QA) group and the Good Clinical Practice Quality and Compliance Council (GCP QCC).
- Represents the GCTO organization both internally and externally within the industry in the country.
- Represents GCTO in the local subsidiary management team ( could be extended leadership team)
- In case of line manager of GCTo staff
- Responsible for ensuring appropriate scientific and operational training for staff members.
- Effectively manage resources to ensure appropriately skilled and high performing staff members are assigned to support the effective execution of the portfolio and achieve GCTO, GCD, and OUR RESEARCH & DEVELOPMENT DIVISION objectives. Sets clear performance standards and holds self and organization accountable for achieving results. Embraces GCTO metrics and performance standards (KPI's)
CORE Competency Expectations
- Knowledge in Site Management.
- Strong organizational skills with demonstrated success required.
- Requires ability to make decisions independently and oversee important activities relevant to clinical research activities in the country according to predetermined global policies and commitments with the support, oversight and supervision of the CRM Manager or CRD
- Requires strong understanding of local regulatory environment for the individual to weigh
- pros and cons of key decisions with input from manager.
- Strong scientific and clinical research knowledge is required for this position.
- Strong understanding of clinical trial planning, management and metrics is essential as well as the ability to focus on multiple deliverables and protocols simultaneously.
- Ability to collaborate with different stakeholders within GCTO and OUR RESEARCH & DEVELOPMENT DIVISION in a matrix organization.
- Ability and skills to manage resource allocation, processes (and controls), productivity, quality and project delivery
- Strong Communication skills requiring proficiency in written and spoken English and local language. The incumbent must be competent and effective in written and verbal communication.
- Strategic thinking
Behavioral Competency Expectations
- High emotional intelligence
- Leadership skills that enable and drive alignment with the goals, purpose and mission of Our company's Research Labs (OUR RESEARCH & DEVELOPMENT DIVISION), Global Clinical Development (GCD) and GCTO
- Ability to identify problems, conflicts and opportunities early and lead, analyse and prepare mitigation plans and drive conflict resolution is critical.
- Required to negotiate skillfully in tough situations with both internal and external groups; settle differences with minimum noise; win concessions without damaging relationships; be both direct and forceful as well as diplomatic; gain trust quickly from other parties in negotiations and have an excellent sense of timing. Examples of common problems include 1) low patient recruitment, 2) inadequate staff to meet business needs, 3) performance or compliance issues, 4) working with regulatory issues and the broader organization, and 5) resolution of conflictive situations on country level.
- Requires skills to effectively build and maintain professional relationships with investigators and other external stakeholders, requiring strong communication, educational/pedagogic, diplomatic and empathic skills.
- Experience Requirements
Required
- 10 years of experience job experience. 
 
Priority
- People Management experience
- Saudi Market experience
- Educational Requirements
Required
- Bachelor degree in Science (or comparable)
Preferred
- Advanced degree, (e.g., , Master degree, MD, PhD)
Current Employees apply HERE
Current Contingent Workers apply HERE
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 
Employee Status
Regular 
Relocation
VISA Sponsorship
*Travel Requirements 
 Flexible Work Arrangements *
Not Applicable 
Shift
Valid Driving License
Hazardous Material(s)
*Required Skills *
Adaptability, Clinical Research, Clinical Research Management, Clinical Trial Documentation, Clinical Trial Management, Clinical Trial Management Processes, Clinical Trial Planning, Clinical Trials Monitoring, Clinical Trials Operations, Communication, Cross-Cultural Awareness, Decision Making, Ethical Standards, Good Clinical Practice (GCP), Leadership, Management Process, Oncology Trials, People Leadership, Production Operations, Product Operations 
*Preferred Skills 
 Job Posting End Date *
10/13/2025 
- A job posting is effective until PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Requisition ID
R  
Country Lead Associate Director Clinical Research
Posted today
Job Viewed
Job Description
Job Description
This role combines the accountability of a clinical research manager and certain elements of a GCTO country lead role. Holders of this position are accountable for:
- The performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, Our company's policies and procedures, quality standards and adverse event reporting requirements internally and externally
- Under the oversight of the CRD, providing leadership to a country: liaising with local country Management team, participating in the local medical governance and providing oversight for the GCTO team in the country serving as a primary point of contact for managing clinical trial execution in all its aspects across phases I/II through III/IV in that country It could include line management of the GCTO our company's employees if required
Responsibilities include, but are not limited to:
CRM component ( Minimum of 50% of time expected to be project related, to be defined according to the need):
- Point of Contact (POC) for assigned protocols between Country Operations (CO) and clinical trial team (CTT) ( or ROC where applicable)
- Pro-actively drives/tracks execution and performance of deliverables/timelines/results to meet country commitments for assigned protocols. Strong collaboration with local CO roles. Forecasts country resource needs. Serves local business needs (signs contracts, manages budgets as delegated).
- Responsible for quality and compliance in assigned protocols in country in close collaboration with CRAs and local study team. Reviews Monitoring Visits Reports and Escalates performance issues and training needs to CRA manager and/or functional vendor and internal management as needed.
- Responsible for collaboration with functional outsourcing vendors, investigators, other external partners. Oversees country and site validations, site selection and recruitment in assigned protocols. Responsible for clinical trial education to sites. Country POC for programmatically outsourced trials for assigned protocols.
- Collaborates internally with local PV, Regulatory, GMA/GHH to align on key decisions in his/her studies. Significantly impacts on the ability to effectively conduct clinical studies and develop the pipeline, while maintaining local regulatory and compliance requirements in countries. The position has a significant impact on how a country can deliver country-specific trial commitments and objectives. As a customer-facing role, this position will build business relationships and represent our company's with investigators, functional outsourcing partners and other external partners and therefore have a significant impact on country-level customer relationships.
- Oversee country commitments, compliance and training needs. Additionally, business leadership and alignment with corporate requires that individual has ability to lead across several dimensions simultaneously.
- Works collaboratively with Country, Regional and HQ Operations; Pharmacovigilance, Regulatory, Global Medical Affairs and Global Human Health internally; and with external functional outsourcing vendors. Requires coordination and alignment with the regional and broader organization. Additionally, will work to build and maintain relationships with investigators and other external partners and promote the company reputation. In collaboration with CRD and/or CRM manager represents our company's in Pharma industry issues and in seeking influence in external R&D environment.)
Country Lead component (% of time to be defined according to the needand always less than 50% or less than 25% if no line management is included.)
- Work collaboratively in a matrix organization with all groups within GCTO, especially with Clinical Sciences and Study Management (CSSM), Clinical Quality Managers (CQMs), to deliver objectives.
- Collaborate with Functional Service Provider (FSP) local Leadership to ensure adequate and appropriate resourcing for the Our company's internal clinical trial portfolio
- Collaborate with Clinical Research Organization (CRO) local Leadership to ensure the successful implementation of fully-outsourced clinical trials
- Represents GCTOin the Medical Governace council.
- Support the development and management of Investigator relationships in conjunction with the OUR RESEARCH & DEVELOPMENT DIVISION Therapy Areas, and when appropriate, Human Health colleagues. Contribute to the program life-cycle management through effective study allocation and execution (prioritizing programs, working with KOLs, etc.).
- Take responsibility for any subsidiary clinical audits, working closely with the Quality Assurance (QA) group and the Good Clinical Practice Quality and Compliance Council (GCP QCC).
- Represents the GCTO organization both internally and externally within the industry in the country.
- Represents GCTO in the local subsidiary management team ( could be extended leadership team)
- In case of line manager of GCTo staff:
o Responsible for ensuring appropriate scientific and operational training for staff members.
o Effectively manage resources to ensure appropriately skilled and high performing staff members are assigned to support the effective execution of the portfolio and achieve GCTO, GCD, and OUR RESEARCH & DEVELOPMENT DIVISION objectives. Sets clear performance standards and holds self and organization accountable for achieving results. Embraces GCTO metrics and performance standards (KPI's) 
CORE Competency Expectations:
- Knowledge in Site Management.
- Strong organizational skills with demonstrated success required.
- Requires ability to make decisions independently and oversee important activities relevant to clinical research activities in the country according to predetermined global policies and commitments with the support, oversight and supervision of the CRM Manager or CRD
- Requires strong understanding of local regulatory environment for the individual to weigh
- pros and cons of key decisions with input from manager.
- Strong scientific and clinical research knowledge is required for this position.
- Strong understanding of clinical trial planning, management and metrics is essential as well as the ability to focus on multiple deliverables and protocols simultaneously.
- Ability to collaborate with different stakeholders within GCTO and OUR RESEARCH & DEVELOPMENT DIVISION in a matrix organization.
- Ability and skills to manage resource allocation, processes (and controls), productivity, quality and project delivery
- Strong Communication skills requiring proficiency in written and spoken English and local language. The incumbent must be competent and effective in written and verbal communication.
- Strategic thinking
Behavioral Competency Expectations:
- High emotional intelligence
- Leadership skills that enable and drive alignment with the goals, purpose and mission of Our company's Research Labs (OUR RESEARCH & DEVELOPMENT DIVISION), Global Clinical Development (GCD) and GCTO
- Ability to identify problems, conflicts and opportunities early and lead, analyse and prepare mitigation plans and drive conflict resolution is critical.
- Required to negotiate skillfully in tough situations with both internal and external groups; settle differences with minimum noise; win concessions without damaging relationships; be both direct and forceful as well as diplomatic; gain trust quickly from other parties in negotiations and have an excellent sense of timing. Examples of common problems include: 1) low patient recruitment, 2) inadequate staff to meet business needs, 3) performance or compliance issues, 4) working with regulatory issues and the broader organization, and 5) resolution of conflictive situations on country level.
- Requires skills to effectively build and maintain professional relationships with investigators and other external stakeholders, requiring strong communication, educational/pedagogic, diplomatic and empathic skills.
- Experience Requirements:
Required:
- 10 years of experience job experience. 
 
Priority:
- People Management experience
. Saudi Market experience
- Educational Requirements:
Required:
- Bachelor degree in Science (or comparable)
Preferred:
- Advanced degree, (e.g., , Master degree, MD, PhD)
Current Employees apply HERE
Current Contingent Workers apply HERE
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 
Employee Status:
Regular
Relocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Not Applicable
Shift:
Valid Driving License:
Hazardous Material(s):
Required Skills:
Adaptability, Clinical Research, Clinical Research Management, Clinical Trial Documentation, Clinical Trial Management, Clinical Trial Management Processes, Clinical Trial Planning, Clinical Trials Monitoring, Clinical Trials Operations, Communication, Cross-Cultural Awareness, Decision Making, Ethical Standards, Good Clinical Practice (GCP), Leadership, Management Process, Oncology Trials, People Leadership, Production Operations, Product Operations
Preferred Skills:
Job Posting End Date:
10/13/2025
- A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Requisition ID:R
Experienced Clinical Research Associate Sponsor-dedicated
 
                        Posted 9 days ago
Job Viewed
Job Description
Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.
**Essential Functions**
- Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and Good Clinical Practice.
- Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability.
- Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
- Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
- Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
- Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements.
- Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
- Collaborate and liaise with study team members for project execution support as appropriate.
- If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.
- If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.
**Qualifications**
- High School Diploma or equivalent Degree in scientific discipline or health care preferred.
- Requires at least 2 years of year of on-site monitoring experience.
- Equivalent combination of education, training and experience may be accepted in lieu of degree.
- Good knowledge of, and skill in applying, applicable clinical research regulatory requirements.
- i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
- Good therapeutic and protocol knowledge as provided in company training.
- Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).
- Written and verbal communication skills including good command of Arabic and English language.
- Organizational and problem-solving skills.
- Effective time and financial management skills.
- Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.
To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.
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