Expert Clinical Trial Documentation - Clinical Trial Associate (CTA)

Octapharma; Lachen; Vor Ort; CHF 90.000 - 130.000; Vollzeit

Zusammenfassung

Octapharma is seeking a Clinical Trial Documentation Specialist to set up and maintain TMFs and ISFs, while supporting the clinical team with regulatory submissions and trial documentation across international trials. You will track essential documents, ensure audit readiness, and act as the central point of contact for trial documentation.

The role requires English fluency and experience with CTMS/TMF systems, plus strong MS Office and Adobe Acrobat DC skills.

Qualifikationen

• Minimum 1 year as CTA/documentation expert in international trials (3 years for senior).
• Fluent in written and spoken English; German preferred.

Aufgaben

• Set up and maintain TMFs and ISFs per SOPs.
• Support clinical team in preparing trial documents and regulatory submissions.
• Track trial documents (insurance certificates, confidentiality agreements, study contracts).
• Maintain audit readiness through TMF checks and quality control.
• Act as central contact for trial documentation and communications.
• Manage returning/archiving TMF documents.
• Assist in Investigator Meetings organization.
• Perform admin tasks to support clinical trial execution.
• For senior: Data Protection/Information Security Champion responsibilities; SOP development; vendor evaluation and oversight.

Kenntnisse

CTA Documentation

English fluency

German (preferred)

CTMS experience

TMF systems experience

MS Office

Adobe Acrobat DC

Prioritize workload

Multitasking

Teamwork & independence

Tools

CTMS software

TMF systems

Jobbeschreibung

Dr. Cristina Solomon, Global Vice President CRD Lachen

Job-ID: 63846

Location: Lachen, CHE

Job Level: Professionals

Category: Research and Development

Employment Type: Permanent position

Become part of a vital chain and contribute to our common goal of making people’s lives better. Headquartered in Lachen, Switzerland, Octapharma is one of the largest human protein manufacturers in the world, developing and producing medicines sourced from human plasma and human cell lines. We are a privately-owned company, where the warmth of family meets the scale of a global organisation.

Join us in shaping our vision to provide new health solutions advancing human life.

Your Main Tasks And Responsibilities

• Set up and maintain Trial Master Files (TMFs) and lnvestigator Site Files (ISFs) according to Octapharma SOPs
• Support the Clinical Team in preparing clinical trial documents and documentation for 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. Support audits and inspection preparation and execution with regards to the TMF
• Act as a central contact for trial documentation, designated project communications, support ad hoc tasks
• Manage returning/archiving of TMF documents
• Assist in the organization of lnvestigator Meetings
• Perform various administrative tasks to support team members with clinical trial execution, as required (e.g. literature search or document formatting review for regulatory submissions)
• In addition, for the senior position:
• Assume Data Protection / Information Security Champion responsibilities
• Assists in development of SOPs
• Perform vendor evaluation and oversight for selected vendors

Your expertise and ideal skill set

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

Your department - where you make an impact

• The Clinical Research and Development (CR&D) team in Lachen develops medicines that target complex and life-threatening conditions in Haematology and Critical Care
• We specialize in clinical development of new as well as already marketed products
• The successful candidate will work closely with CPMs, CTMs, and colleagues across CR&D in Lachen to support a wide variety of clinical trials
• This position reports to the Global Senior Director CR&D in Lachen and is a permanent role within the team.

“Join an international environment with exciting projects and responsibilities — be proactive, contribute, and grow together with a great team”

Thrive with us

• You help save lives - Every day is meaningful as we produce life-saving medicines
• Family values - Long-term perspective for employees and relationships
• Be rewarded with market-related salary and benefits package
• You will have a high level of influence where you can make a difference and leave your footprint
• Work with skilled and fun colleagues in a relatively informal organization
• Skills development - We offer various internal and external employee and leadership trainings, trainee programs and digital solutions

It´s in our blood

We live diversity and stand for equal opportunities as an employer! We therefore look forward to receiving your application - regardless of age, gender, origin, sexual orientation, and religion.

Please apply in English.

Do you have any questions? Then get in touch with your contact person.

Claudia Vignau

Senior Expert Talent & Acquisition

Octapharma AG

Seidenstrasse 2, 8853 Lachen

T: [phone]

About Octapharma

Octapharma is one of the largest human protein manufacturers in the world, developing and producing human proteins from human plasma and human cell lines. We employ more than 11,000 people worldwide to support the treatment of patients in 120 countries with products across three therapeutic areas: Immunotherapy, Haematology and Critical Care. With seven R&D sites and five state-of-the-art manufacturing facilities in Austria, France, Germany, and Sweden, Octapharma also operates over 200 plasma donation centres across Europe and the US. With four decades of experience, we are committed to advancing patient care worldwide.