Skills Alliance Enterprise

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:
<ul>
<li>Maintain study trackers, dashboards, and project management plans</li>
<li>Update Gantt charts and project timelines in collaboration with the CPM</li>
<li>Manage spreadsheets and project management tools (e.g. MS Project; Monday.com)</li>
<li>Assist in developing and maintaining Risk Management Plans</li>
<li>Track study metrics</li>
<li>Serve as back-up for the CPM during absences</li>
</ul>
Leading Document Management and eTMF Processes alongside the CPM to ensure excellent eTMF set up and maintenance carrying out the following:
<ul>
<li>Set up, organize, and maintain clinical study documentation files</li>
<li>Ensure version control and proper filing of documents within SharePoint and the Trial Master File (TMF)</li>
<li>Responsible for TMF content management for inspection readiness and ensuring threshold metrics are met</li>
<li>Performing eTMF uploads and QC checks</li>
<li>Working closely with vendors to ensure up-to-date checklists</li>
<li>Preparing for internal/external audits and periodic checks</li>
<li>Conducting final reconciliations and archiving</li>
<li>Assist in preparing Investigator Site Files (ISF) during site set-up</li>
<li>Review and quality control study documents (e.g., Informed Consent Forms)</li>
<li>Coordinate translation of study documents</li>
</ul>
Supporting Vendor and Site Management with the CPM on the following processes:
<ul>
<li>Support vendor management and oversight</li>
<li>Assist in country, site, and patient management</li>
<li>Maintain regular communication with clinical trial vendors</li>
<li>Coordinate with sites for specific requests (e.g., enrollment updates, missing documentation)</li>
<li>Track invoices and maintain purchase order oversight</li>
</ul>
To ensure Meeting Coordination and Communication by:
<ul>
<li>Preparing agendas, PowerPoint slides, and meeting minutes for Clinical Study Team meetings</li>
<li>Coordinating meetings with vendors and investigators</li>
<li>Assisting in organizing Investigator/Monitor meetings</li>
</ul>
Regulatory and Ethics Support:
<ul>
<li>Under CPM delegation, prepare Ethics Committee/Institutional Review Board (EC/IRB) submission packages</li>
<li>Understand regulatory and ethics processes across all sectors</li>
<li>Provide input into the content of ethics submissions</li>
</ul>
Cross-functional Coordination:
<ul>
<li>Work closely with the CPM and various departments (e.g., Data Management) in a matrix environment</li>
<li>Coordinate transversally to ensure successful and timely study execution</li>
<li>Take ownership of specific tasks/projects within the Project Management Team</li>
</ul>
Additional Responsibilities:
<ul>
<li>Support clinical supply management by liaising with Clinical Supply Chain or external service providers</li>
<li>Assist in budget management and invoice reconciliation</li>
<li>Contribute to risk and issue identification and mitigation planning</li>
<li>Flexibility to handle various organizational and administrative aspects of the trial</li>
</ul>
Demonstrated Skills and Competencies
E – Essential P – Preferred
Experience:
<ul>
<li>Minimum of 5 years’ previous experience of working in Clinical Research or the Pharmaceutical Industry as a Clinical Trials Administrator or similar role (E)</li>
<li>Experience in Clinical Trials in Hem/Onc (P)</li>
<li>Pragmatic problem-solving abilities built up through experience of different Trial Projects</li>
</ul>
Qualifications:
<ul>
<li>Degree or equivalent experience</li>
</ul>
Skills/Specialist Knowledge:
<ul>
<li>Good knowledge of maintenance of Project Files and TMFs (E)</li>
<li>Good knowledge of the Industry/Clinical trial process (E)</li>
<li>Good knowledge of ICH-GCP (E)</li>
<li>A highly effective communicator, both orally and in writing with an eye for detail and accuracy (E)</li>
<li>Strong organisational, time management and communication skills (E)</li>
<li>Self-motivated taking personal pride in delivering on personal and corporate objectives (E)</li>
<li>Microsoft Office Skills - excellent proficiency in Word, Excel, PowerPoint and Outlook required (E)</li>
<li>Knowledge of Project Management Programmes is preferred</li>
</ul>

Clinical Project Associate

Clinical Project Associate

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