Clinical Operations Leader - Oncology Experience Required - UK - FSP

CTI Clinical Trial and Consulting Services; Uxbridge; Remote; GBP 60,000 - 90,000; Full time

Job summary

A leading clinical research organization seeks a Local Study Associate Director to oversee clinical trials in the UK. The role involves managing study components, ensuring compliance with regulations, and leading cross-functional teams. Ideal candidates will have extensive experience in clinical operations and a strong understanding of trial management.

Qualifications

• Minimum of 3 years' experience running local clinical trials.
• Proven ability to lead and motivate cross-functional teams.
• Good understanding of clinical research, trial phases, GCP/ICH, and local laws.

Responsibilities

• Responsible for delivering components of clinical studies according to resources, budget, and timelines.
• Leads and optimizes the performance of the Local Study Team(s).
• Prepares and maintains an accurate study budget.

Skills

Leadership

Time Management

Problem Solving

Organizational Skills

Interpersonal Skills

Job description

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 tremendous long-term job security and prospects. We undertake vital clinical studies for sponsors including leading global biotechs and Pharma top 50, with an incredible pipeline of work.

Whether you see your future in clinical operations, project management, line management, or other positions, 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 exciting professional challenges in inspiring studies, balanced with time for your outside life.

Specifics About This Role

• Dedicated to one client.
• Responsible at the country level for delivering components of clinical studies according to resources, budget, and timelines, complying with Client Procedural Documents, ICH-GCP, and local regulations.
• Prepares country financial Study Management Agreement (fSMA) and maintains an accurate study budget in the client financial system through regular checks.
• Leads and optimizes the performance of the Local Study Team(s), ensuring compliance with procedural documents and regulations.
• Prepares country-level Master Informed Consent Form (MICF) and site-level ICFs, including translations, in line with SOPs and regulations.
• Submits applications/documents to EC/IRB at study start-up and throughout the study.

Requirements

• Minimum of 3 years' experience running local clinical trials.
• Proven ability to lead and motivate cross-functional teams to deliver trials on time, within budget, and with quality.
• Experience in, and willingness to monitor, oncology trials if needed based on capacity.
• Experience with submissions to RA and EC.
• Ability to partner with study functions for smooth delivery.
• Strong time management, organizational, interpersonal, and problem-solving skills, with the ability to multitask and prioritize.
• Good understanding of clinical research, trial phases, GCP/ICH, and local laws and guidelines.

We value our people and your passion, providing an open and friendly environment that empowers career development. You will have opportunities to grow within your role and take on additional responsibilities or explore other departments within Parexel.

About Parexel

Parexel supports clinical studies across various therapeutic areas, with longstanding partnerships with a vast client base. We have contributed to trials for most of today’s top 50 best-selling drugs and also support niche developments vital to patient well-being.

You will be an influential member of our wider team.

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