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 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 R365893
