Proclinical is seeking a Senior Regional Clinical Operations Lead to head up a team of Regional Clinical Operations Leads.
This role focuses on ensuring excellence in project management, feasibility, oversight, and compliance within various regions.
You will act as a point of contact for Local Medical Affairs, facilitating collaboration between Global Medical Clinical Operations and local teams.
This is a hybrid position in either London or Paris.
Responsibilities: Lead and manage the team of Regional Clinical Operations Leads to ensure excellence in execution of evidence generation activities.
Maintain and manage relationships with sites, KOLs, and HCPs in collaboration with global and local teams.
Provide thought leadership and guidance on alignment with global and local priorities.
Collaborate with GMA Clinical Operations Leadership and Senior Clinical Project Managers to ensure alignment in priorities and delivery.
Oversee local evidence generation activities, ensuring feasibility, performance, execution oversight, and compliance.
Provide expertise in GCP or RWE data generation regulations to assess clinical study design.
Support LMA in tracking and monitoring local evidence generation activities, ensuring delivery to time, budget, and quality.
Serve as a regional point of contact for Global Medical Evidence generation activities.
Co-monitor Global Medical Affairs clinical studies, ensuring adequate contact with investigator sites and resolving study progress issues.
Review and input into local/regional proposals/documentation for Evidence Generation Review Board submissions.
Liaise with Local and Regional clinical operational teams, Patient Safety Managers, and Quality Assurance teams to ensure oversight and risk management.
Ensure compliance with inspection-readiness needs and monitor team compliance with required trainings and certifications.
Key Skills and Requirements: Relevant experience in pharmaceutical drug development (Ph2, Ph3) or RWE/HEOR, NIS studies, including project management of national and international programs.
Proven track record of delivering projects to time, budget, and quality.
Extensive experience interacting with country Medical Affairs Staff.
Knowledge of Good Clinical Practice (GCP) and non-GCP data regeneration regulations.
Experience in line-managing people and working with multidisciplinary groups.
Ability to manage and develop relationships with Service Providers.
Excellent organizational, management, verbal, and written communication skills.
Bachelor's or Master's degree in life sciences or equivalent.
If you are having difficulty in applying or if you have any questions, please contact Sam Rodriguez at ****** Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.
Proclinical Staffing is an equal opportunity employer.