APX Life Sciences
Contract Clinical Trial Lead / Associate Director, Clinical Operations
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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.
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About You
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- 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.
“It took my CV and asked me questions relevant to understanding what kind of jobs to suggest for me. Suggestions were almost perfect. Jobs were exactly what I’ve been looking for.”
Jessica, London
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