Clinical Trial Associate in City of Westminster

The Clinical Trial Associate supports the planning, execution, and coordination of clinical development activities across various functional areas, including clinical operations, outsourcing, medical experts, project management, pharmacology, supply, and biometrics. This entry-level role assists in the evaluation of product safety, efficacy, and marketability while maintaining adherence to timelines, protocols, and regulatory requirements.

Responsibilities

• Attend study team and vendor meetings, and maintain the study Action, Decision, Issue (ADI) logs, finalizing, and distributing to the study teams.
• Assist with the planning and management of the operational aspects of clinical trials, including CRO and vendor management/oversight, ensuring project milestones and objectives are entered into the appropriate clinical systems.
• Lead study TMF filing, management, oversight, & reconciliation activities, including interaction and coordination of all essential internal TMF contributing functions and the responsible CRO according to ICH-GCP, company SOPs and WIs.
• Overall responsibility of Trial Master File (TMF): set up, maintenance and archiving for clinical studies.
• For out-sourced studies, control administrative work ensuring CRO maintains a complete trial master file and organized shipment to Galderma in the appropriate format at the end of the study.
• For in-sourced studies, assure filing on an ongoing basis of a complete TMF (including insurance, translations, approvals, etc.).
• Complete TMF Quality Control and subsequent Quality Assurance audit resolution in collaboration with Clinical Team.
• Assure administrative archiving of the TMF.
• Ensure consistency and set up between all outsourced studies to our TMF structure.
• Setup and ensure, in conjunction with the Clinical Trial Manager (CTM), that study related systems (CTMS, eTMF, Smartsheets) are updated on a regular basis.
• Assist study team in managing study start-up, conduct and close‑out activities and other project related activities.
• Support clinical trial insurance activities including the filing and tracking of new country policies and renewals.
• Ensure study training tracking and reconciliation is completed in joint with the Clinical Trial Manager (CTM).
• Assist the CTMs/Study Teams in preparation of Audits or Inspections and participate in Audit and Inspection interviews, as required.
• Assist study team in the conduct of studies and ensure they are implemented according to the study protocols and in compliance with local, ICH, GCP and company policies and procedures.
• Assist with oversight of operational activities from start‑up to close‑out to ensure deliverables are prioritized and goals and objectives are met.
• Assist with the development and review of study‑related documents, including clinical protocols, ICFs, CRFs, monitoring plans, study, laboratory and pharmacy manuals, data management plans, etc.
• Assist the study team with report creation and review for study metrics and/or KPIs.
• Collaborate with internal and external team members for the planning and execution of clinical trials.
• Assemble final clinical study report appendices; ensure final report completeness in collaboration with Clinical Team.
• Maintain reporting and managing document lifecycles in electronic document management system (EDMS).
• Assist in the set up and maintenance of public registries.
• Help with formatting documents (i.e., protocols, amendments, letters, plans, etc.), as needed.
• Support Inspection Readiness activities for priority projects, as assigned, including coordination of study oversight activities.
• Contribute to workshops / special initiatives as Subject Matter Experts.
• Maintain Study Team Rosters and Study related system access.
• Maintain knowledge and usage of databases and platforms used by the department.
• Other duties as assigned.
• Ensure all activities follow SOPs, GCP, and relevant country‑specific regulations.

Qualifications

• Bachelor's degree or equivalent experience in life sciences, clinical research, or related field.
• Less than 2 years of relevant professional experience.
• Basic understanding of clinical trial processes, SOPs, and GCP guidelines.
• Ability to navigate and manage stakeholder relationships.
• Detail‑oriented with the ability to follow established procedures.
• Excellent verbal and written communication, interpersonal, organizational, and time‑management skills.
• Proficiency in standard office software (e.g., Microsoft Word, Excel, Outlook, Teams, SharePoint).