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Clinical Trials Director

1 month ago

Uxbridge, United Kingdom Parexel Full time

Unlock Your Potential in Clinical Trials

Parexel FSP is seeking a dedicated and experienced Clinical Trials Director to join our team in the UK. As a key member of our clinical trials operations team, you will be responsible for delivering high-quality clinical trials to our clients.

Key Responsibilities:

  • Lead and manage cross-functional teams to deliver clinical trials according to or ahead of time plan, budget, and with required quality.
  • Ensure timely preparation of country financial Study Management Agreement (fSMA) and maintain accurate study budget in client clinical studies financial system.
  • Optimize the performance of the Local Study Team(s) at country level, ensuring compliance with client Procedural Documents, ICH-GCP, and local regulations.
  • Prepare and submit application/documents to EC/IRB at start-up and for the duration of the study.

Requirements:

  • Minimum of 3 years' experience running local clinical trials.
  • Proven ability to lead and motivate cross-functional teams to deliver clinical trials according to or ahead of time plan, budget, and with required quality.
  • Experience in, and willingness to monitor oncology clinical trials - if needed based on flexible capacity.
  • Experience performing submissions to RA and EC.
  • Effective time management, organizational, and interpersonal skills & problem-solving skills, with the ability to multi-task and prioritize.
  • Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines.