At a Glance
- Tasks: Lead global Phase I clinical trials and collaborate with cross-functional teams.
- Company: Dynamic biotech company focused on innovative clinical operations.
- Benefits: Competitive contract rate, hybrid working, and potential for permanent role.
- Other info: Opportunity for career growth in a fast-paced, collaborative environment.
- Why this job: Make a real impact in clinical research while working flexibly.
- Qualifications: 8+ years in clinical trial management and strong project management skills.
The predicted salary is between 60000 - 80000 £ per year.
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 Clinical Trials. 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.
Contract Clinical Trial Lead / Associate Director, Clinical Operations employer: APX Life Sciences
Join a dynamic biotech company that values innovation and collaboration, offering you the chance to lead impactful global Phase I clinical trials. With a strong focus on employee growth, you'll benefit from a flexible hybrid working arrangement and a competitive contract rate, all while working in a supportive environment that encourages continuous improvement and excellence in clinical operations. This role not only allows you to influence study strategy but also positions you at the forefront of cutting-edge research in a fast-paced industry.
