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 remotely.
- 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 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.
Contract Clinical Trial Lead / Associate Director, Clinical Operations in Stevenage 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.
