Expert Clinical Trial Documentation - Clinical Trial Associate

Expert Clinical Trial Documentation \- Clinical Trial Associate (CTA)

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.

Vignau

Senior Expert Talent \& Acquisition

Octapharma AG

Seidenstrasse 2, 8853 Lachen

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• 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. jpid5481217jm jit0833jm jiy26jm