127 Cancer Research jobs in Saudi Arabia

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

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

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

If you want to do your next step as a CRA, this is your chance

You'll have training and development to plan and progress your career in the direction you choose. And you won't do it alone – you will have dedicated mentoring and receive structured quarterly reviews on performance, promotion and bonus awards.

While Projects Vary, Your Typical Responsibilities Might Include

• Performing site selection, initiation, monitoring and close-out visits, plus maintaining appropriate documentation
• Supporting the development of a subject recruitment plan
• Establishing regular lines of communication plus administering protocol and related study training to assigned sites
• Evaluating the quality and integrity of site practices – escalating quality issues as appropriate
• Managing progress by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution

You will need to be comfortable collaborating and communicating with a variety of colleagues and customers. Ideally, you will also have a good basic knowledge of applicable clinical research regulatory requirements.

You Should Have

• A Bachelor's degree in a health care or other scientific discipline or educational equivalent
• At least 1,5 - 2 years of on-site monitoring experience
• Fluent in Arabic and English language
• Good written and verbal communication skills including good command of English language
• Requires frequent travel to sites
• Flexible about location, but location must have good connectivity to travel
• Homebased

If you want to make an impact in the global research market, where we are working to make a real difference in patient health, we ask you to
apply now and join our team
.

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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

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

Overview

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.

• 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 Visit 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 the ability to effectively conduct clinical studies and develop the pipeline, while maintaining local regulatory and compliance requirements in countries. Represents the company with investigators and external partners and has a significant impact on country-level customer relationships.
• Oversee country commitments, compliance and training needs. Leads across several dimensions simultaneously as required by business leadership and alignment with corporate requirements.
• Works collaboratively with Country, Regional and HQ Operations; Pharmacovigilance, Regulatory, Global Medical Affairs and Global Human Health, and with external functional outsourcing vendors. Coordinates with regional and broader organization. Builds and maintains relationships with investigators and external partners and promotes the company reputation. Represents the company in Pharma industry issues and external R&D environments in collaboration with CRD and/or CRM manager.

• Country Lead component (% of time to be defined according to the need and 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 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 GCTO in the Medical Governance council.
• Support the development and management of Investigator relationships in conjunction with 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 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 management 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 (KPIs).

• 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

• 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 in the job.
• Priority: People Management experience; Saudi Market experience.
• Educational Requirements: Required: Bachelor degree in Science (or comparable); Preferred: Advanced degree (e.g., Master, 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: Not Applicable

VISA Sponsorship: Not Applicable

Travel Requirements: Not Specified

Flexible Work Arrangements: Not Applicable

Shift: Not Specified

Valid Driving License: Not Specified

Hazardous Material(s): Not Specified

Job Posting End Date: 10/13/2025

Overview

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:

• 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 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.

(% of time to be defined according to the need and 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 GCTO in the Medical Governance 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 (KPIs).

• 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

• 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

Note: 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.

Overview

Country Lead Associate Director Clinical Research. This role combines the accountability of a clinical research manager and 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 accordance with ICH/GCP and country regulations, company policies and procedures, quality standards and adverse event reporting requirements internally and externally.

• Performance and compliance for assigned protocols in the country in alignment with ICH/GCP, country regulations, company policies and procedures, quality standards and adverse event reporting requirements.
• Under the oversight of the CRD, provide leadership to the country, liaising with the local country Management team, participating in local medical governance, and providing oversight for the GCTO team in the country. Serve as a primary point of contact for managing clinical trial execution across phases I/II through III/IV in that country. May include line management of GCTO company employees if required.

• Work collaboratively in a matrix organization with all groups within GCTO, especially Clinical Sciences and Study Management (CSSM), Clinical Quality Managers (CQMs,
• Collaborate with Functional Service Provider (FSP) local leadership to ensure adequate resourcing for the company’s internal clinical trial portfolio
• Collaborate with Clinical Research Organization (CRO) local leadership to ensure successful implementation of fully-outsourced clinical trials
• Represent GCTO in Medical Governance council
• Support the development and management of Investigator relationships in conjunction with the OUR RESEARCH & DEVELOPMENT DIVISION therapy areas, contributing to program lifecycle management through study allocation and execution
• Take responsibility for subsidiary clinical audits, working closely with QA and GCP QCC
• Represent the GCTO organization internally and externally within the industry in the country
• Represent GCTO in the local subsidiary management team (may be extended leadership team)
• Responsible for ensuring appropriate scientific and operational training for staff members
• Effectively manage resources to ensure appropriately skilled and high-performing staff are assigned to support portfolio execution and achieve GCTO, GCD, and OUR R&D objectives; set performance standards and comply with GCTO metrics

• Knowledge in Site Management
• Strong organizational and decision-making abilities; ability to oversee activities relevant to clinical research in-country with support from CRM Manager or CRD
• Strong understanding of local regulatory environment; weigh pros and cons of key decisions with manager input
• Strong scientific and clinical research knowledge
• Strong understanding of clinical trial planning, management, and metrics; ability to manage multiple deliverables and protocols
• Ability to collaborate with stakeholders within GCTO and OUR R&D in a matrix organization
• Ability to manage resource allocation, processes, productivity, quality, and project delivery
• Strong written and spoken English and local language communication skills
• Strategic thinking

• High emotional intelligence
• Leadership to align with the goals of OUR R&D, GCD, and GCTO
• Ability to identify problems, conflicts and opportunities and drive mitigation plans
• Effective negotiation and relationship-building with internal and external groups
• Ability to build and maintain professional relationships with investigators and external stakeholders
• Experience: >10 years of relevant experience

• Bachelor degree in Science (or comparable)
• Preferred: Advanced degree (e.g., Master’s, MD, PhD)

Job Posting End Date: