Senior Clinical Trials Development Manager

1 month ago


Maidenhead, Windsor and Maidenhead, United Kingdom Lifelancer Full time

About the Role

We are seeking an experienced Senior Clinical Trials Development Manager to join our team at Lifelancer. As a key member of our clinical operations team, you will be responsible for leading the development and execution of clinical trials from protocol design to final study report.

Key Responsibilities

  • Lead and manage integration of all project team activities, leveraging internal and development partner resources, expertise, and knowledge, along with optimizing CRO resources, expertise, and knowledge.
  • Provide strategic input and execution of clinical trials from protocol design to the final clinical study report for specified studies.
  • Provide leadership and input into global subject/patient recruitment plans.
  • Effectively communicate and interact with Key Opinion Leaders.
  • Manage all aspects of CRO/vendor identification, request for proposal submission, CRO selection, and the day-to-day operational management activities of CROs, development of Key performance Indicators (KPIs), management of global resources, expertise, and knowledge within the CRO/vendor.
  • Manage strategic study operations including: study sites and tracking systems for regulatory submissions, CRO KPIs, drug supply and use, enrollment of subjects, regulatory document flow, study timelines, all budgetary and financial information, Pharmacovigilance/Serious Adverse Events, performance metrics, data flow, etc.
  • Participate in Case Report Form design, user acceptance testing in partnership with data management.
  • Generate country-specific Informed Consent Form(s).
  • Lead the development of contingency/risk management plans for projects and assist Director/Senior Director of Clinical Operations in the preparation and execution of sound development strategies.
  • Provide support to clinical trial managers within and/or across programs.
  • Budgets, timelines, and forecasts preparation for clinical studies.
  • Interface with Finance, Program Management, Accounting, Supply Operations, Quality Assurance, Clinical Research, Commercial, Regulatory, Medical Affairs; which may include leading sub-teams and/or acting as a liaison between groups.

Requirements

  • Bachelor's Degree is required. An advanced degree in a scientific and/or business/finance discipline is preferred.
  • 3+ years of clinical research experience gained with a CRO or Pharmaceutical Company working on later stage (Phase 2-4) multinational clinical studies. Experience in rare diseases and/or difficult to recruit patient populations preferred.
  • 1-3+ years clinical project management experience with global clinical studies.
  • Strong regulatory knowledge, including Good Clinical Practices (GCPs).
  • Exceptional organizational skills and ability to deal with competing priorities, also strong reasoning and problem-solving ability.
  • Excellent communication (written and verbal) and presentation skills along with leadership qualities.
  • Knowledge of global clinical trial management in fast-paced CRO outsourced environment. Ability to assemble a plan and execute on the details.
  • Apply project management best practices to programs. Experience in novel clinical drug development.
  • Experience with protocol, ICF, CRF, CSR development and review.

About Us

Lifelancer is a talent-hiring platform in Life Sciences, Pharma, and IT. We connect talent with opportunities in pharma, biotech, health sciences, healthtech, and IT domains. We are committed to building an inclusive and diverse community that values creativity, collaboration, and innovation.

Estimated Salary Range: £60,000 - £90,000 per annum, depending on experience.



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