Clinical Operations Director

1 week ago


Leeds, Leeds, United Kingdom Lifelancer Full time
About the Role

We are seeking a highly experienced Senior Clinical Trials Manager to join our team at Parexel in the UK. As a key member of our operations team, you will be responsible for delivering clinical studies within agreed resources, budget, and timelines.

Key Responsibilities
  • Dedicated to one client, responsible for country-level delivery of clinical studies according to agreed resources, budget, and timelines complying with Client Procedural Documents, ICH-GCP, and local regulations.
  • Timely preparation of country financial Study Management Agreement (fSMA) and maintaining accurate study budget in client clinical studies financial system by regular checks of the system and financial reports.
  • Leading and optimizing the performance of the Local Study Team(s) at country level ensuring compliance with client Procedural Documents, ICH-GCP, and local regulations.
  • 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.
  • 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.
  • Experience partnering with study functions to ensure smooth delivery.
  • 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.
Compensation Package

The estimated salary range for this role is £70,000 - £90,000 per annum, depending on experience. The company offers a comprehensive benefits package, including medical insurance, pension scheme, and generous holiday entitlement.



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