Clinical Project Manager

1 month ago

London, Greater London, United Kingdom ProPharma Group Full time
Clinical Project Manager Job Description

ProPharma Group is seeking a highly skilled Clinical Project Manager to join our Clinical Operations Team. As a Clinical Project Manager, you will be responsible for overseeing the planning and execution of clinical research trials, ensuring they are conducted in accordance with applicable regulations and that the quality of clinical data generated meets the requirements for Regulatory Authority approval.

Key Responsibilities:
  • Plan and manage assigned studies from start to close out.
  • Manage project timelines and project budget.
  • Proactively anticipate and understand concerns/issues/delays.
  • Develop risk assessments and contingency plans.
  • Hold each functional area responsible for associated risk mitigation and management.
  • Primary source of communication for the clinical project team, cross-functional project teams, and internal and external stakeholders.
  • Participate in project kick-off meetings.
  • Provide regular updates to clients and manage communication between team members and clients.
  • Monitor project budget vs. cost and ensure project margins are met.
  • Provide study-specific training for clinical operations staff as appropriate.
  • Evaluate and identify resourcing needs and monitor over the life cycle of the study.
  • Develop, analyze, and report study metrics to Sponsor per Project Plan and proactively identify and communicate any risks or concerns.
  • Develop and maintain Study Project Plans.
  • Provide strategic input into study documents.
  • Manage study drug product and non-drug site supplies.
  • Develop the agenda and manage the planning and execution of Investigator Meetings.
  • Responsible for the development and presentation of slides and training materials for various audiences.
  • Assist with vendor selection (ECG, Lab, IWRS, IRB, Raters) and contracting.
  • Ensure clinical study team compliance with applicable FDA/ex-US regulations, ICH-GCPs, other local regulatory requirements, and corporate SOPs.
  • Develop subject recruitment/retention strategy and related initiatives for assigned studies.
  • Oversee maintenance and quality review of study TMF.
Requirements:
  • Relevant Bachelor's degree or advanced degree (e.g., Master, PharmD, PhD). Candidates with equivalent combination of education, training, and experience will be considered.
  • Several years of clinical trial and research experience.
  • Knowledge of FDA and/or ex-US Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials.
  • Experience managing/mentoring and developing junior staff.
  • Demonstrated experience in change management initiatives.

ProPharma Group is an Equal Opportunity Employer and celebrates our differences. We strive to create a workplace where each person can be their authentic self. We provide a safe space where all employees feel empowered to succeed.

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