Clinical Trial Documentation Specialist

Octapharma-Plasma; Lachen; Vor Ort; CHF 90.000 - 120.000; Vollzeit

Zusammenfassung

Octapharma is seeking an Expert Clinical Trial Documentation - CTA in Lachen, CH. You will set up and maintain TMFs/ISFs, support regulatory submissions, and track trial documents across the lifecycle.

The role requires 1 year CTA experience in international trials, fluent English (German a plus), proficiency with CTMS and TMF systems, and strong organizational skills. The senior position adds data protection duties, SOP development, and vendor oversight.

Qualifikationen

• Minimum 1 year of CTA/documentation experience in international clinical trials or similar (3 years for the senior position).
• Fluent in both written and spoken English; German is a plus.
• Experience with various CTMS and TMF systems.
• Excellent command of Microsoft Office applications and Adobe Acrobat DC.
• Able to prioritize workload with attention to detail and timelines.
• Able to learn on the job and apply new knowledge to future challenges.
• Able to manage multiple tasks with a positive and flexible attitude.
• Strong operational, organizational, documentation, communication, and interpersonal skills.

Aufgaben

• Set up and maintain Trial Master Files (TMFs) and Investigator Site Files (ISFs) according to Octapharma SOPs.
• Support the Clinical Team in preparing clinical trial documents and regulatory submissions.
• Track clinical trial documents such as insurance certificates, confidentiality agreements and study contracts throughout the trial lifecycle.
• Maintain audit and inspection readiness through periodic review of TMF accuracy and completeness, quality control checks, and a unified TMF management approach.
• Act as a central contact for trial documentation and designated project communications.
• Manage returning/archiving of TMF documents.
• Assist in the organization of Investigator Meetings.
• Perform various administrative tasks to support team members with clinical trial execution.
• Senior position: Assume Data Protection / Information Security Champion responsibilities; Assist in SOP development; Perform vendor evaluation and oversight.

Kenntnisse

CTA experience

English

German

TMF Systems

CTMS

MS Office

Documentation

Organizational skills

Tools

CTMS software

TMF tools

Adobe Acrobat DC

Jobbeschreibung

Octapharma is seeking an Expert Clinical Trial Documentation - CTA in Lachen, CH. You will set up and maintain TMFs/ISFs, support regulatory submissions, and track trial documents across the lifecycle.

The role requires 1 year CTA experience in international trials, fluent English (German a plus), proficiency with CTMS and TMF systems, and strong organizational skills. The senior position adds data protection duties, SOP development, and vendor oversight.