Clinical Project Associate

Skills Alliance Enterprise; Greater London; On-site; GBP 42,000 - 64,000; Full time

Job summary

Skills Alliance Enterprise is seeking a Clinical Project Associate to support the Clinical Project Manager in end-to-end trial management, from study setup to close-out. You will help maintain study documentation, coordinate with vendors and departments, and ensure efficient trial execution.

The role emphasizes building TMF content, coordinating with sites, and contributing to regulatory submissions, with a focus on Hem/Onc trials and strong attention to detail.

Qualifications

• Minimum of 5 years’ experience in Clinical Research or pharmaceutical industry as a Clinical Trials Administrator or similar role.

Responsibilities

• Maintain study trackers, dashboards, and project management plans.

Skills

Project management

Communication

Documentation

MS Office

Education

Degree or equivalent experience

Tools

MS Project

Monday.com

Job description

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

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

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