Clinical Trial Documentation Specialist

Octapharma AG; Lachen; Vor Ort; CHF 80.000 - 110.000; Vollzeit

Zusammenfassung

Octapharma AG seeks an Expert Clinical Trial Documentation - CTA to support TMF/ISF setup and ongoing trial documentation across international studies. You will aid the clinical team with regulatory submissions, track critical documents, and help ensure audit readiness.

Strong MS Office and Adobe Acrobat DC skills are essential. The role requires English fluency and experience with CTMS/TMF systems; German is a plus.

Qualifikationen

• 1 year minimum as a CTA/documentation expert in international trials; 3 years for senior
• Fluent in written and spoken English; German preferred
• Experience with CTMS and TMF systems
• Excellent command of MS Office and Adobe Acrobat DC
• Ability to prioritise workload, detail-oriented, and meet timelines
• Ability to learn on the job and apply knowledge to future challenges
• Ability to manage multiple tasks with a positive, 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 SOPs
• Support the Clinical Team in preparing trial documents for regulatory submissions
• Track trial documents such as insurance certificates, confidentiality agreements and study contracts
• Maintain audit and inspection readiness with TMF QA checks and unified TMF management
• Act as central contact for trial documentation and communications
• Manage returning/archiving of TMF documents
• Assist in organizing Investigator Meetings
• Perform admin tasks to support clinical trial execution
• For senior role: Data Protection/Information Security Champion responsibilities
• For senior role: assist in SOP development
• For senior role: vendor evaluation and oversight

Kenntnisse

Clinical trial documentation

CTA experience

Attention to detail

Time management

Teamwork

Tools

CTMS systems

Microsoft Office

Adobe Acrobat DC

Jobbeschreibung

Octapharma AG seeks an Expert Clinical Trial Documentation - CTA to support TMF/ISF setup and ongoing trial documentation across international studies. You will aid the clinical team with regulatory submissions, track critical documents, and help ensure audit readiness.

Strong MS Office and Adobe Acrobat DC skills are essential. The role requires English fluency and experience with CTMS/TMF systems; German is a plus.