Expert Clinical Trial Documentation - Clinical Trial Associate (CTA)

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

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.

Expert Clinical Trial Documentation - Clinical Trial Associate (CTA)

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”
- Dr. Cristina Solomon, Global Vice President CRD Lachen

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]

Want to find out more about us?

Visit our website Octapharma Career and follow us daily on LinkedIn.

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 195 plasma donation centres across Europe and the US. With four decades of experience, we are committed to advancing patient care worldwide.