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 on the following aspects of a trial:
- 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 alongside the CPM to ensure excellent eTMF set up and maintenance carrying out the following:
- 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 with the CPM on the following processes:
- 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
To ensure Meeting Coordination and Communication by:
- 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
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
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