Clinical Operations Manager

1 month ago


Uxbridge, United Kingdom Lifelancer Full time
Life Sciences Talent Platform: Exciting Role for Clinical Operations Leader

Parexel, a renowned company in the life sciences industry, is seeking an experienced Clinical Operations Leader to join their team in the UK. This role presents an excellent opportunity for professionals looking to advance their careers in clinical operations, project management, or other related fields.

In this position, you will work as a Local Study Associate Director (LSAD), supporting studies within your country or region from your home office base. You will be assigned to one of Parexel's key sponsors and will be responsible for delivering committed components of clinical studies according to agreed resources, budget, and timelines.

The successful candidate will have a minimum of 3 years' experience running local clinical trials and 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. They will also have experience in, and willingness to monitor oncology clinical trials, performing submissions to regulatory authorities, and partnering with study functions to ensure smooth delivery.

This role offers tremendous long-term job security and prospects, along with an incredible pipeline of work. As a valued member of the team, you will have the opportunity to develop your skills and knowledge in clinical research, phases of clinical trials, and current GCP/ICH country clinical research law guidelines.

Key Responsibilities:

  • Deliver committed components of clinical studies according to agreed resources, budget, and timelines.
  • 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 preparation of country financial Study Management Agreement (fSMA) and maintains accurate study budget in client clinical studies financial system.
  • Prepare 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.

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 problem-solving skills, with the ability to multi-task and prioritize.

Benefits:

Tremendous long-term job security and prospects.Incredible pipeline of work.Opportunity to develop skills and knowledge in clinical research, phases of clinical trials, and current GCP/ICH country clinical research law guidelines.

Salary: The estimated salary for this role is £60,000 - £80,000 per annum, depending on experience and qualifications.



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