Clinical Trials Director
3 weeks ago
Local Study Associate Director - Remote - FSP
Parexel is currently seeking a Local Study Associate Director to join us in the UK, assigned to one of our key sponsors in the region.
Working as a Local Study Associate Director at Parexel FSP offers tremendous long-term job security and prospects.
Our LSADs work from their home office base, supporting studies within their country or region.
- Responsible at country level to deliver committed components of clinical studies according to agreed resources, budget, and timelines, complying with Client Procedural Documents, international guidelines such as ICH-GCP, as well as relevant local regulations.
- Ensures timely preparation of country financial Study Management Agreement (fSMA) and maintains accurate study budget in client clinical studies financial system by regular checks of the system and financial reports.
- Leads and optimizes the performance of the Local Study Team(s) at country level ensuring compliance with client Procedural Documents, ICH-GCP, and local regulations.
- Ensures timely preparation of country level Master Informed Consent Form (MICF) and subsequent site level ICFs, as required, including any relevant translations, and in line with relevant client SOPs and local regulations.
Key requirements for this role include:
- 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.
- Effective time management, organizational, and interpersonal skills, with the ability to multi-task and prioritize.
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