Head of Country Operations (Director) - Clinical Operations

This job is with MSD, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please read the information in this job post thoroughly to understand exactly what is expected of potential candidates.

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 will 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 align 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.
• Bachelor's 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.

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