Senior TMF Operations Lead – EMEA/LATAM

Worldwide Clinical Trials; Warszawa; Vor Ort; PLN 90.000 - 130.000; Vollzeit

Zusammenfassung

Worldwide Clinical Trials is seeking a TMF Operations professional to lead material management, quality control, and documentation for complex sponsor studies. The role emphasizes cross-functional collaboration, regulatory compliance, and KPI analysis across TMF processes.

Candidates should have a life sciences background, 2–4 years of relevant experience in regulated environments, and strong communication skills to interact with sponsors and project teams.

Qualifikationen

• Proficient understanding of clinical research principles, industry standards and regulations applicable to TMF Management.
• Strong planning and organizational skills with ability to work under pressure.
• Strong interpersonal and written/verbal communication skills for fast-paced environments.
• Ability to identify regulatory compliant solutions including complex technical situations.
• Experience in regulated industry or CRO/pharma company is desirable.

Aufgaben

• Perform RMC Lead Activities for complex studies or Sponsor portfolio.
• Coordinate with Project Team and Sponsors to assess TMF needs and provide SME guidance.
• Oversee Quality Control, including planning, reporting and follow-up on non-compliance.
• Assist in developing project-specific TMF Quality Management Documents.
• Prepare, maintain and present TMF KPIs and data analysis trends with Project Teams and Sponsors.
• Support Regulatory and Sponsor audits and audit finding resolutions.

Kenntnisse

TMF knowledge

Planning

Interpersonal skills

Communication

Regulatory thinking

Ausbildung

University degree preferred (Life Science desirable)

Jobbeschreibung

Worldwide Clinical Trials is seeking a TMF Operations professional to lead material management, quality control, and documentation for complex sponsor studies. The role emphasizes cross-functional collaboration, regulatory compliance, and KPI analysis across TMF processes.

Candidates should have a life sciences background, 2–4 years of relevant experience in regulated environments, and strong communication skills to interact with sponsors and project teams.