Job Description

Executive Director, Clinical Trial Operations

The Clinical Research Director (CRD) is the Clinical Operations lead in a country/cluster and is responsible for execution of all Clinical Trials in scope for Global Clinical Trial Operations (GCTO) country operations.

Adherence to GCP, local and global policies and procedures to conduct high-quality, inspection ready studies is essential. The position is accountable for trial quality and audit responses and completion of CAPAs. The incumbent ensures a single point of contact for managing clinical trial execution in all its aspects across phases in scope of GCTO within the country/cluster.

The position has multiple touch points across the company which will be dependent on country/cluster and the study type and stage.

The CRD is the primary country/ cluster level contact for GCTO and has the following key responsibilities:

Supports the regional GCTO leadership team, leading strategic development of their country / cluster to deliver clinical trials as per global clinical research pipeline requirementStrategic country / cluster representative for initiatives at all levels of the organizationBuild and lead the team to effectively manage resources ensuring appropriately skilled and high performing team to effectively deliver the portfolio across therapy areas and achieve on agreed GCTO, GCD, and Research Division objectivesLeads strategic development and management of institutional & investigator relationships in conjunction with Research Division / GCD Therapy Areas, and when appropriate Human HealthWorking with regional and global colleagues develops and executes the GCTO strategy for the country/cluster - such as Industry associations

Leadership and Management of the GCTO country / cluster Organization:

Recruits and hires talentProactively manages and develops talentProactively identifies new opportunities and gaps to support emerging needs and addresses by reallocating and training of existing staff and/or external recruitmentCreates an empowering, compliant, collaborative, and innovation-focused work environmentBuilds a culture of quality and compliance through training, oversight, and collaboration
Oversight to ensure appropriate scientific and operational training for staff members.
Clinical Operation Management: Ensures a single point of contact for managing clinical trial execution in all its aspects across all studies & phases in scope of GCTO within the country/cluster.

Leadership and oversight of the following:

Research Division / GCD / GCTO goals, initiatives and expectationsDevelopment and delivery of company standards in given geographyActivities of all cluster/country level GCTO team & all programs and studiesApproved administrative budget to support GCTO team (e.g., salaries & travel)Country level operational study budgetsRegulatory Inspections and internal audits; responding to inquiries by health authorities, ethics committees, and internal auditors in conjunction with CCQM, compliance, Regulatory, Pharmacovigilance (PV) and Medical AffairsResponsible and supports development of audit responses and completion of CAPAs.

To be successful in this role, you will have the following skills and experience:

Significant Management experience in clinical trials with a pharmaceutical organisation with the ability to service and collaborate with different stakeholders within GCTO and the wider Research division in a matrix organizationManagement expertise should cover management of budget, travel, resources, headcount, processes (and controls), productivity, quality and project deliveryA complete understanding of ICH GCP and Global/Regional/Local regulatory requirements is required.Strong Communication skills requiring proficiency in written and spoken English and preferably local language. The incumbent must be competent and effective in written and verbal communication.

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, Budget Management, Clinical Research Organizations (CRO) Management, Clinical Trial Planning, Clinical Trials Monitoring, Clinical Trials Operations, Cross-Cultural Awareness, Ethical Standards, ICH GCP Guidelines, Mentorship, People Leadership, Resource Allocation, Results-Oriented, Risk Management, Strategic Thinking

 Preferred Skills:

Job Posting End Date:

06/25/2025

*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:R353258