Clinical Operations Leader
1 week ago
Lifelancer is a talent-hiring platform connecting professionals with opportunities in life sciences, pharma, and IT.
Job Description:Clinical Operations Leader Role Overview
This role involves working as a Local Study Associate Director (LSAD) at Parexel FSP, supporting studies within the UK region. The ideal candidate will have experience running local clinical trials and lead cross-functional teams to deliver clinical trials according to or ahead of time plan, budget, and quality.
The LSAD will be responsible for managing sites, protocols, and ensuring compliance with client procedural documents, international guidelines, and local regulations. They will also be involved in preparing country financial Study Management Agreements and maintaining accurate study budgets.
Key Responsibilities:
- Deliver committed components of clinical studies according to agreed resources, budget, and timelines.
- Ensure timely preparation of country financial Study Management Agreements and maintain accurate study budgets.
- Lead and optimize the performance of the Local Study Team(s) at country level.
- Prepare country level Master Informed Consent Forms and subsequent site level ICFs.
- Submit applications/documents to EC/IRB at start-up and during the study duration.
Requirements:
- Minimum 3 years' experience running local clinical trials.
- Proven ability to lead and motivate cross-functional teams.
- Experience in monitoring oncology clinical trials.
- Experience performing submissions to RA and EC.
- Effective time management, organizational, and interpersonal skills.
- Good understanding of clinical research, phases of clinical trials, GCP/ICH country clinical research law guidelines.
Benefits:
Parexel offers long-term job security and prospects, along with an incredible pipeline of work. As a Local Study Associate Director, you can expect exciting professional challenges while having time for your outside life.
Estimated Salary Range:
£60,000 - £80,000 per annum, depending on experience.
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