Head of Site Management and Monitoring (Director) - UK&I

Job Description

As the Head of Site Management and Monitoring, you will make a significant impact on the success of our clinical studies and the development of our pipeline. You will be instrumental in our site management, territory development, and UK&I study support. Leading a team of CRA Managers, and CRAs, you will ensure exceptional study performance whilst adhering to local regulations, Standard Operating Procedures (SOPs), and ICH Good Clinical Practice (GCP) guidelines.

You will play an integral role in our UK&I Leadership team and directly influence our ability to meet the needs of patients.

What You Will Do:

• Oversee monitoring resources and assess CRA capacity to ensure high-quality monitoring deliverables across all projects.

• Lead a team of 5 CRA Managers, with responsibility for a large team of CRAs, cultivating key talent within your team and fostering a high-performance culture.

• Work closely with our Clinical Research Director, Therapy Area Leads, CRA Managers, and Vendor Management to build strong relationships with principal investigators and sites.

• Partner with vendors and internal stakeholders to develop resourcing and monitoring strategies that meet the current and future needs of our pipeline.

• Build productive collaborations with investigators, regulators, and industry partners to support clinical study execution.

• Uphold local regulations and quality standards in monitoring, while executing strategic quality initiatives to enhance operational excellence.

• Be an integral part of the local leadership team, supporting strategic initiatives across clinical development and operations.

What you will need:

• Significant experience within a pharmaceutical, clinical trial organisation in a functional management position

• Ideally CRA experience

• Management of CRAs and familiarity with outsourcing and flexible resourcing models

• Bachelors degree in Science or equivalent healthcare experience

• Ability to travel up to 30% of the time.

• Business and financial acumen with the ability think strategically, cross-functionally and internationally

• Ability to identify problems, conflicts and opportunities early and lead, analyse mitigation plans and drive conflict resolution

• Excellent ICH-GCP knowledge and knowledge of Good Documentation Practices

• A good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines

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.

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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:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Required Skills:

Adaptability, Adaptability, Biopharmaceutical Industry, Clinical Development, Clinical Research, Clinical Site Management, Clinical Study Design, Clinical Testing, Clinical Trial Documentation, Clinical Trial Management, Clinical Trial Planning, Clinical Trials Operations, Decision Making, Emotional Intelligence, Ethical Standards, ICH GCP Guidelines, Maintenance Management, Manufacturing Compliance, Multiple Therapeutic Areas, People Leadership, Process Improvements, Professional Networking, Quality Initiatives, Quality Management, Resource Allocation + 2 more

Preferred Skills:

Job Posting End Date:

06/9/2025

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.

Requisition ID:R349390