Executive Director, Clinical Trial Operations
Executive Director, Clinical Trial Operations
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Job Description
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 requirement
- Strategic country / cluster representative for initiatives at all levels of the organization
- Build 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 objectives
- Leads strategic development and management of institutional & investigator relationships in conjunction with Research Division / GCD Therapy Areas and when appropriate Human Health
- Working 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 talent
- Proactively manages and develops talent
- Proactively identifies new opportunities and gaps to support emerging needs and addresses by reallocating and training of existing staff and/or external recruitment
- Creates an empowering compliant collaborative and innovation-focused work environment
- Builds 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 expectations
- Development and delivery of company standards in given geography
- Activities of all cluster/country level GCTO team & all programs and studies
- Approved administrative budget to support GCTO team (e.g. salaries & travel)
- Country level operational study budgets
- Regulatory 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 Affairs
- Responsible 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 organization
- Management expertise should cover management of budget travel resources headcount processes (and controls) productivity quality and project delivery
- A 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.
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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:
RegularRelocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Not ApplicableShift:
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 ThinkingPreferred Skills:
Job Posting End Date:
06/25/2025*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Required Experience:
Director
Employment Type
Full-Time
