Clinical Trial Associate/TMF Manager

Coopers Group GmbH; Basel; Vor Ort; CHF 100’000 - 120’000; Vollzeit

Zusammenfassung

A leading clinical operations firm is looking for a Clinical Operations Specialist to oversee the Trial Master File and manage various operational tasks for clinical trials. The successful candidate will ensure compliance with regulations while supporting clinical study execution and vendor management. Ideal candidates will have extensive experience in TMF management and be adept at working within cross-functional teams to drive successful project outcomes.

Qualifikationen

• Minimum 3 years of experience required.
• Strong knowledge of TMF management principles and practices.
• Experience in global clinical trials with the ability to work independently.

Aufgaben

• Oversee creation and maintenance of the Trial Master File.
• Ensure TMF documents are accurate, complete, and compliant.
• Support day-to-day operations of clinical studies.

Kenntnisse

TMF management principles

Clinical operations

Communication

Problem-solving

Project management

Tools

TMF systems

Electronic document management systems (EDMS)

Jobbeschreibung

Contract duration: 1 year

Responsibilities:

• Overseeing the creation, maintenance, and quality of the Trial Master File, a collection of essential documents for a clinical trial and TMF archival
• Ensuring TMF documents are accurate, complete, and compliant with regulations (e.g., ICH/GCP) and internal/external SOPs.
• Supporting day-to-day operations of clinical study execution in compliance with applicable SOPs, ICH/GCP guidelines, and other regulatory requirements
• Preparing agendas, taking minutes, and managing action points for various CTT or other meetings, as required
• Tracking of subjects and site activity metrics, performing quality check activities across components of the clinical study, etc.
• Supporting trial budget management, including vendor budgets, actual/invoice tracking, and reporting variances
• Project management of some CTT activities, such as document development
• Supporting vendor RFP, evaluation, and selection activities
• Overseeing one or more operational vendors providing key services, e.g. TMF-platform vendor
• Participating in process improvement and quality-related initiatives associated with study execution and deliverables
• Providing operational input and updates to the DOL and CTT
• Supporting the organization of virtual and face-to-face CTT meetings
• Supporting the organization of virtual and face-to-face Investigator Meetings

Requirements:

• Min 3 year of experience
• Strong knowledge of TMF management principles and practices
• Experienced clinical operations professional working several years on global clinical trials, with a strong ability to work independently and within cross-functional teams
• Good knowledge of drug development and ICH/GCP
• Experience with TMF systems and electronic document management systems (EDMS)
• Excellent organizational, communication, and problem-solving skills