Contract Clinical Trial Lead / Associate Director, Clinical Operations

Clinical Trial Lead / Associate Director

Contract | 6 Months (Potential to Convert to Permanent)

Are you an experienced Clinical Trial professional looking to lead global early-phase studies in a fast-paced biotech environment? We’re seeking a Contract Clinical Trial Lead / Associate Director to drive the successful delivery of a global, multi-centre Phase I clinical trial, working with cross-functional teams, CROs, and external partners from study start-up through close-out.

This is an excellent opportunity to play a key leadership role in clinical operations, influencing study strategy while ensuring quality, compliance, and timely execution.

Location

• Remote in either the UK or US – If US, ideally within the Cambridge, MA area (1–2 days onsite but not essential).
• Remote candidates with relevant experience may also be considered.

Key Responsibilities

• Lead cross-functional study teams through the start-up and execution of a global, multi-centre Phase I clinical trial.
• Act as the primary operational lead for assigned studies, partnering closely with internal stakeholders, CROs, and vendors.
• Contribute to study strategy, including protocol development, country and site selection, vendor management, risk assessment, timelines, and budgets.
• Oversee the preparation and maintenance of essential study documentation, including informed consent forms, monitoring plans, regulatory submissions, GDPR documentation, and annual reports.
• Manage CRO and vendor performance, ensuring high-quality delivery, issue resolution, and strong collaborative relationships.
• Identify and mitigate study risks, escalating issues appropriately to maintain study timelines and quality.
• Ensure compliance with ICH-GCP, SOPs, and applicable regulatory requirements throughout all study activities.
• Support inspection readiness, audits, regulatory inspections, and CAPA activities.
• Partner with Finance and Legal teams on study budgets, contracts, invoice reviews, change orders, and financial oversight.
• Oversee Trial Master File (TMF) management and ensure accurate, timely updates to clinical trial registries such as ClinicalTrials.gov.
• Drive continuous improvement initiatives across Clinical Operations to enhance efficiency and best practices.

About You

• Bachelor’s degree in Life Sciences, Healthcare, or a related discipline (advanced degree preferred).
• Minimum of 8 years’ clinical trial management experience within the biotech or pharmaceutical industry.
• Strong experience managing CROs and external vendors across global clinical studies.
• Thorough understanding of ICH-GCP and global regulatory requirements, including FDA and EMA guidelines.
• Proven project management skills with the ability to manage multiple priorities in a fast-paced environment.
• Excellent communication, stakeholder management, and organisational skills.
• Self-motivated with the ability to work both independently and collaboratively within cross-functional teams.
• Willingness to travel up to 15%, including occasional international travel.

What’s on Offer

• 6-month contract with strong potential for permanent conversion or extension.
• Opportunity to lead an impactful global Phase I clinical trial.
• Collaborative and innovative biotech environment.
• Competitive contract rate.
• Hybrid working arrangement with flexibility.

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