Clinical Operations Director
3 weeks ago
Clinical Operations Leader - Oncology Experience Required
Parexel is currently seeking a Clinical Operations Leader to join us in the UK.
As a Clinical Operations Leader, you will work from your home office base, supporting studies within your 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.
Here are a few requirements specific to this role:
- 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.
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