Senior Regional Clinical Operations Lead

2 months ago

London Area, United Kingdom Proclinical Staffing Full time

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 s.rodriguez@proclinical.com


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.

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