Senior Clinical Study Manager

4 weeks ago

Elstree, United Kingdom Bio Products Laboratory Limited Full time
Job Title: Senior Clinical Study Manager

Bio Products Laboratory Limited is seeking a highly skilled and experienced Senior Clinical Study Manager to join our Global Clinical Research & Operations department.

This is a challenging and rewarding role that involves overseeing the entire process from protocol concept to final study report for regional or global clinical trials, including phases I to IV and non-interventional data collections.

Key Responsibilities:
  • Ensure compliance with regulations and company policies, meeting timelines and budget requirements, and maintaining high standards of patient safety and data quality.
  • Oversee the entire process from protocol concept to final study report, including phases I to IV and non-interventional data collections.
  • Develop, review, and finalize study-specific plans and forms, including case report forms and statistical analysis plans.
  • Ensure correct reporting of safety events and monitor/co-monitor at study sites to standards required by the company.
  • Liaise with Procurement and GCR&O colleagues in request for proposal and selection of suppliers, and manage and oversee setup, study delivery, and close-out activities.
  • Develop and manage overall life of study budget, including forecasting, setup, and approval, phasing, and invoice reconciliation.
  • Identify out-of-scope work in stream, and manage any change order required for new scope or out-of-scope activity.
  • Initiate and develop study or site risk and action plans, and plan for periodic study risk review and propose risk mitigation strategies.
  • Ensure sites and vendors are conducting the trial in compliance with appropriate regulations, and ensure any findings and observations are addressed to resolution.
Requirements:
  • Science degree or equivalent.
  • Relevant work experience within the clinical research environment within the Pharmaceutical or allied Industry.
  • Skilled in problem-solving, independent decision-making, and possesses strong communication abilities.
  • Ability to engage with senior personnel and healthcare professionals, along with a good understanding of Good Clinical Practice and regulatory requirements.
What We Offer:
  • Competitive salary.
  • Bonus.
  • 25 days holiday.
  • Pension.
  • Life insurance.
  • Private health insurance.
  • On-site parking.
  • Employee assistance programme.
  • My Healthy Advantage phone app.
  • Virtual GP.
  • Cycle to work scheme.

We are based in Elstree, just north of London, on a secure campus surrounded by natural beauty, greenery, lakes, and wildlife. We employ just over 1000 colleagues who are involved in the full operation of a pharmaceutical company, involving everything from the Research & Development of new products, manufacturing our medicines, Engineering support of existing and new equipment, logistics and planning, and many more in between.

We take immense pride in the value and impact our therapies have and we work collaboratively together to achieve the demands of our patients.

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