Clinical Trials Director
4 weeks ago
About the Role
Parexel is seeking a skilled Clinical Trials Director to join our team in the UK. As a key member of our team, you will be responsible for delivering clinical studies according to agreed resources, budget, and timelines, complying with client procedural documents, international guidelines, and relevant local regulations.
Key Responsibilities
- Ensure timely preparation of country financial Study Management Agreement (fSMA) and maintain accurate study budget in client clinical studies financial system.
- Lead and optimize the performance of the Local Study Team(s) at country level, ensuring compliance with client Procedural Documents, ICH-GCP, and local regulations.
- Ensure timely submission of 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, with the ability to multi-task and prioritize.
About Parexel
Parexel is a leading global biopharmaceutical services company, providing a comprehensive range of solutions to help clients accelerate the development and delivery of new and innovative treatments. We have a strong presence in the UK and are committed to delivering high-quality clinical trials that meet the needs of our clients and patients.
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