Skills Alliance Enterprise
Clinical Project Associate
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Clinical Project Associate
9-month contract
Remote | London, UK
May require travel into office 1-2x/mo.
£80-95/hr - Inside IR35
About our Client
Our client is a biopharmaceutical company, advancing innovative therapies at both clinical and commercial stages of development, focused on next-generation, programmed T cell therapies for the treatment of cancer. Using a broad suite of proprietary and modular T cell programming technologies, the company is engineering precisely targeted, controlled, and highly active T cell therapies designed to better recognize cancer cells, break down their defense mechanisms, and eliminate these cells. They have a pipeline of product candidates in development for the treatment of hematological malignancies, solid tumours, and autoimmune diseases.
Role Summary
The Clinical Project Associate (CPA) supports the Clinical Project Manager (CPM)/Clinical Program Lead (CPL) in all aspects of clinical trial management, from study set-up through close-out. This role is responsible for maintaining study documentation, coordinating with various departments and vendors, and ensuring efficient trial execution.
Key Responsibilities
Working closely with the lead CPM to provide Project Management Support
- Maintain study trackers, dashboards, and project management plans
- Update Gantt charts and project timelines in collaboration with the CPM
- Manage spreadsheets and project management tools (e.g. MS Project; Monday.com)
- Assist in developing and maintaining Risk Management Plans
- Track study metrics
- Serve as back-up for the CPM during absences
Leading Document Management and eTMF Processes
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- Set up, organize, and maintain clinical study documentation files
- Ensure version control and proper filing of documents within SharePoint and the Trial Master File (TMF)
- Responsible for TMF content management for inspection readiness and ensuring threshold metrics are met
- Performing eTMF uploads and QC checks
- Working closely with vendors to ensure up-to-date checklists
- Preparing for internal/external audits and periodic checks
- Conducting final reconciliations and archiving
- Assist in preparing Investigator Site Files (ISF) during site set-up
- Review and quality control study documents (e.g., Informed Consent Forms)
- Coordinate translation of study documents
Supporting Vendor and Site Management
- Support vendor management and oversight
- Assist in country, site, and patient management
- Maintain regular communication with clinical trial vendors
- Coordinate with sites for specific requests (e.g., enrollment updates, missing documentation)
- Track invoices and maintain purchase order oversight
Meeting Coordination and Communication
- Preparing agendas, PowerPoint slides, and meeting minutes for Clinical Study Team meetings
- Coordinating meetings with vendors and investigators
- Assisting in organizing Investigator/Monitor meetings
Regulatory and Ethics Support
- Under CPM delegation, prepare Ethics Committee/Institutional Review Board (EC/IRB) submission packages
- Understand regulatory and ethics processes across all sectors
- Provide input into the content of ethics submissions
Cross-functional Coordination
- Work closely with the CPM and various departments (e.g., Data Management) in a matrix environment
- Coordinate transversally to ensure successful and timely study execution
- Take ownership of specific tasks/projects within the Project Management Team
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Additional Responsibilities
- Support clinical supply management by liaising with Clinical Supply Chain or external service providers
- Assist in budget management and invoice reconciliation
- Contribute to risk and issue identification and mitigation planning
- Flexibility to handle various organizational and administrative aspects of the trial
Demonstrated Skills and Competencies
E – Essential
P – Preferred
Experience
- Minimum of 5 years’ previous experience of working in Clinical Research or the Pharmaceutical Industry as a Clinical Trials Administrator or similar role (E)
- Experience in Clinical Trials in Hem/Onc (P)
- Pragmatic problem-solving abilities built up through experience of different Trial Projects
Qualifications
- Degree or equivalent experience
Skills/Specialist Knowledge
- Good knowledge of maintenance of Project Files and TMFs (E)
- Good knowledge of the Industry/Clinical trial process (E)
- Good knowledge of ICH-GCP (E)
- A highly effective communicator, both orally and in writing with an eye for detail and accuracy (E)
- Strong organisational, time management and communication skills (E)
- Self-motivated taking personal pride in delivering on personal and corporate objectives (E)
- Microsoft Office Skills - excellent proficiency in Word, Excel, PowerPoint and Outlook required (E)
- Knowledge of Project Management Programmes is preferred (P)
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