Clinical Operations Leader - Oncology Experience Required - UK - FSP

Parexel; Uxbridge; On-site; GBP 50,000 - 80,000; Full time

Job summary

Parexel is seeking a Clinical Operations Leader with oncology experience to manage local clinical trials in the UK. The role involves leading study teams, ensuring compliance with regulations, and delivering study components on time. Candidates should have strong leadership skills and at least 3 years of experience in clinical trial management.

Qualifications

• Minimum of 3 years' experience managing local clinical trials.
• Proven leadership and motivation skills for cross-functional teams.
• Good knowledge of clinical research phases, GCP/ICH guidelines, and local laws.

Responsibilities

• Responsible for delivering clinical study components according to resources, budget, and timelines.
• Leads and optimizes local study teams, ensuring compliance with procedures and regulations.
• Ensures timely submission of applications and documents to EC/IRBs.

Skills

Leadership

Time Management

Problem Solving

Organizational Skills

Interpersonal Skills

Job description

Clinical Operations Leader - Oncology Experience Required - UK - FSP

Parexel Uxbridge, England, United Kingdom

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Clinical Operations Leader - Oncology Experience Required - UK - FSP

Parexel Uxbridge, England, United Kingdom

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Parexel is currently seeking a Local Study Associate Director (Clinical Operations Leader) to join us in the UK. You will be assigned to one of our key sponsors in the region.

Working as a Local Study Associate Director (LSAD) at Parexel FSP offers long-term job security and prospects. We undertake vital clinical studies for sponsors including leading global biotechs and Pharma top 50, with an extensive pipeline of work.

Whether your future path is in clinical operations, project management, line management, or other roles, we offer a world of opportunity.

Our LSADs work from their home office, supporting studies within their country or region. Our mantra is ‘Manageable sites, manageable protocols’. Expect professional challenges in inspiring studies, balanced with your outside life.

Role Details

• Dedicated to one client.
• Responsible at the country level for delivering clinical study components according to resources, budget, and timelines, complying with Client Procedural Documents, ICH-GCP, and local regulations.
• Ensures timely preparation of country financial Study Management Agreement (fSMA) and maintains accurate study budgets in client systems.
• Leads and optimizes local study teams, ensuring compliance with procedures and regulations.
• Prepares country-level Master Informed Consent Forms (MICFs) and site-specific ICFs, including translations, in line with SOPs and regulations.
• Ensures timely submission of applications and documents to EC/IRBs at start-up and during the study.

Candidate Requirements

• Minimum of 3 years' experience managing local clinical trials.
• Proven leadership and motivation skills for cross-functional teams.
• Willingness to monitor oncology trials, if needed.
• Experience with submissions to Regulatory Authorities and Ethics Committees.
• Ability to collaborate with study functions for smooth delivery.
• Strong time management, organizational, interpersonal, and problem-solving skills.
• Good knowledge of clinical research phases, GCP/ICH guidelines, and local laws.

We value our people and your passion. We foster an open, friendly environment that empowers growth and career development. Opportunities to expand your responsibilities or explore other departments are available.

About Parexel

Parexel supports clinical studies across diverse therapeutic areas, partnering with a broad client base. We have contributed to trials for most of today’s top 50 drugs and niche developments vital to patient well-being. Join us as an influential team member.

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