Netherlands
4 days ago
Senior Associate II, TMF Operations
Jobgether
Netherlands
4 days ago
Senior Associate II, TMF Operations
Senior Associate II, TMF Operations needed for a global clinical research environment based in Netherlands. The role involves managing Trial Master Files, ensuring compliance, and collaborating with project teams and sponsors. Requires 2-4 years of experience in clinical research or regulated industries.
RemoteFull-timeMid LevelTMF ManagementClinical Research
Senior Associate II, TMF Operations
Senior Associate II, TMF Operations needed for a global clinical research environment based in Netherlands. The role involves managing Trial Master Files, ensuring compliance, and collaborating with project teams and sponsors. Requires 2-4 years of experience in clinical research or regulated industries.
RemoteFull-timeMid LevelTMF Management
Salary
Not specified
Core Qualifications
Technical (Must-have)
TMF ManagementClinical ResearchRegulatory ComplianceQuality ManagementStakeholder CollaborationData AnalysisRisk ManagementAudit SupportProcess ImprovementDocumentation Standards
Soft Skills
Detail-orientedOrganizedCommunicationInterpersonal SkillsProblem SolvingAttention to DetailCollaborationTime Management
Key Responsibilities
- Manage TMF operations activities for multiple complex studies or sponsor portfolios.
- Collaborate directly with project teams and sponsors to assess TMF requirements and provide subject matter expertise.
- Oversee Trial Master File quality control processes, including planning, tracking, reporting, and follow-up on compliance issues.
- Support the creation and maintenance of project-specific TMF quality management documentation.
- Prepare, maintain, and present TMF key performance indicators and data analysis trends.
- Identify documentation risks and recommend solutions that align with regulatory requirements and industry standards.
- Support regulatory inspections, sponsor audits, and resolution of audit findings when required.
- Partner with cross-functional teams to improve TMF processes and maintain operational excellence.
- Ensure all records management activities follow applicable procedures, regulations, and best practices.
Senior AssociateTMF OperationsClinical ResearchRegulatory ComplianceQuality ManagementRemoteFull-timeNetherlandsPharmaceuticalCRO