This job is with MSD, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.
Job Description
Our Clinical Research team pushes the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine.
In this role, you will be accountable for the execution of UK operations through oversight of project support and regulatory and financial activities. You will manage and lead the strategy and execution of all regulatory, financial and logistics activities associated with insourced clinical studies.
You will play an integral role in our UK Leadership team and be instrumental in our ability to execute our studies in adherence to local regulations, Standard Operating Procedures (SOPs), and ICH Good Clinical Practice (GCP) guidelines. You'll collaborate closely with internal and external stakeholders to drive alignment and enhance the capabilities of our clinical research landscape.
What you will do:
Multi-team leader of a team of Clinical Operation Managers (COM), COM Leads, Sr. COMs and Clinical Trial Coordinators (CTC), cultivating key talent and fostering a high-performance culture
Define and oversee operational strategy for studies within our broad clinical trial portfolio, ensuring streamlined and efficient submissions, contracting, and project support. Ensure oversight of key performance indicators to drive organisational efficiency and the highest quality standards.
Work closely with UK Clinical Research Executive Director and Leadership Team to alignment on project deliverables and ensure smooth cross functional delivery
Direct strategy and operations for rapid start up activities relevant to submissions, contracting and project support
Partner with regional and headquarters-based colleagues to help drive company strategy, with specific focus on standards of practice for site budgeting, site contracting, Informed Consents, and management of Ethics Committees and Health Authorities.
Partner with vendors/service providers that support operational implementation and study execution. Oversee and monitor deliverables critical to the success of operational strategy.
What you will need:
Experience in leadership and oversight of clinical trial operations
In-depth knowledge of MHRA requirements and submissions processes, as well as contracting and financial processes
Bachelors degree in Science or equivalent healthcare experience
Business and financial acumen with the ability to think strategically, cross-functionally and internationally
Excellent ICH-GCP knowledge and knowledge of Good Documentation Practices
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
Required Skills:
Clinical Trial Planning, Clinical Trials Operations, Contract Management, Contract Negotiations, Ethical Standards, ICH GCP Guidelines, Operations Management, Organizational Implementation, Partnership Strategy, People Leadership, Process Improvements, Project Implementations, Strategic Thinking Preferred Skills:
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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:
Regular Relocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Hybrid Shift:
Valid Driving License:
Hazardous Material(s):
Job Posting End Date:
01/9/2026 *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: R376273