Expert Clinical Trial Documentation - Clinical Trial Associate (CTA) — Octapharma
- Location
- Lachen
- Contract
- full-time
- Posted
- 2 days ago
Role overview
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.
- 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.
- Your main tasks and responsibilities
- Set up and maintain Trial Master Files (TMFs) and lnvestigator Site Files (ISFs) according to Octapharma SOPs
Main responsibilities
- 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
- 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
Application process
- 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
- 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 now Find similar jobs:
Contacts
- T: +41 55 451 21 35
- 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.
Company and context
- 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:
- 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.
- 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!
Additional details
- 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
- Strong operational, organizational, documentation, communication, and interpersonal skills, able to work in a team and independently Your department - where you make an impact
- Cristina Solomon, Global Vice President CRD Lachen You help save lives
- Every day is meaningful as we produce life-saving medicines
- 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
- Then get in touch with your contact person. Senior Expert Talent & Acquisition Seidenstrasse 2, 8853 Lachen
- Visit our website Octapharma Career and follow us daily on LinkedIn .
Notes and original content
- 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
- Strong operational, organizational, documentation, communication, and interpersonal skills, able to work in a team and independently
- Your department - where you make an impact
- Cristina Solomon, Global Vice President CRD Lachen
- Thrive with us
Questions about this listing
What salary does Octapharma offer for this role?
Octapharma lists CHF 69'500 - 106'000 gross per year for this position in Lachen. This is the salary published in the original listing (or, when the employer omits a figure, a realistic estimate for the role and sector) — the calculator on this site converts it to your actual net take-home once cross-border tax and social contributions are applied.
Is this a full-time role, and what type of contract does Octapharma offer?
This listing is a full-time position. The contract type shown here comes directly from the employer's original posting; always confirm exact hours, notice period and probation length with Octapharma during the application process, since these details can vary by role even within the same contract category.
Do I need a cross-border work permit for a role in Schwyz?
EU/EFTA residents living in the border zone of the country adjoining Canton Schwyz can apply for a G permit; the Swiss employer files it with that canton's migration office after the contract is signed. Border-zone rules and processing times vary by neighbouring country and canton, so confirm the specifics with Schwyz's cantonal migration office or with HR during the application.
How do I apply for this position at Octapharma?
Use the "Apply now" button on this page — it links directly to Octapharma's original listing at careers.octapharma.com, so your application goes straight to the employer's own applicant-tracking system. Frontaliere Ticino does not collect or forward applications itself.
