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Manager of Clinical Trials

2 months ago

London, Greater London, United Kingdom ProPharma Group Full time

About ProPharma Group: For over two decades, ProPharma has been dedicated to enhancing patient health and wellness by offering expert guidance that empowers organizations in the biotech, medical device, and pharmaceutical sectors to confidently navigate scientific advancements and launch innovative therapies. As the largest Research Consulting Organization (RCO) globally, ProPharma collaborates with clients through a comprehensive advise-build-operate model throughout the entire product lifecycle.

Position Overview: We are seeking a Clinical Project Manager to join our team and play a pivotal role in the strategic and tactical operational planning and execution of various upcoming clinical studies. This position involves overseeing and conducting clinical research trials, ensuring compliance with relevant regulations, and maintaining the integrity of clinical data necessary for regulatory approvals.

Key Responsibilities:

  • Manage and oversee assigned studies from initiation to closure.
  • Oversee project timelines and budgets effectively.
  • Proactively identify and address potential concerns, issues, or delays.
  • Develop risk assessments and implement contingency plans.
  • Ensure accountability for risk mitigation across functional areas.
  • Serve as the primary communication link for the clinical project team and stakeholders.
  • Facilitate project kick-off meetings.
  • Provide regular updates to clients and maintain communication among team members.
  • Monitor project budget against costs to ensure profitability.
  • Deliver study-specific training to clinical operations personnel as needed.
  • Assess and identify resource requirements throughout the study lifecycle.
  • Analyze and report study metrics to sponsors as outlined in the project plan, while identifying and communicating any risks or concerns.
  • Develop and maintain comprehensive Study Project Plans.
  • Contribute strategic insights into study documentation.
  • Manage the logistics of study drug products and non-drug site supplies.
  • Organize and execute Investigator Meetings, including agenda development.
  • Create and present training materials and slides for diverse audiences.
  • Assist in vendor selection and contracting processes.
  • Ensure compliance of the clinical study team with applicable regulations and corporate SOPs.
  • Develop strategies for subject recruitment and retention for assigned studies.
  • Oversee the maintenance and quality review of the study Trial Master File (TMF).

Qualifications:

  • Relevant Bachelor's degree or advanced degree (e.g., Master, PharmD, PhD). Equivalent combinations of education, training, and experience will be considered.
  • Extensive experience in clinical trials and research.
  • In-depth knowledge of FDA and/or international regulations, ICH Guidelines, and GCPs related to clinical trial conduct.
  • Experience in managing, mentoring, and developing junior staff.
  • Proven track record in change management initiatives.

Join Our Team: This role is part of our Clinical Operations Team, where we value diversity, equity, and inclusion. We encourage our employees to express their authentic selves and foster an environment that promotes innovation, collaboration, and entrepreneurial spirit.