Clinical Trial Transparency Lead

vor 13 Stunden

Lausanne, Schweiz Proclinical Vollzeit

An opportunity as opened for a Global Clinical Trial Transparency Lead (mid manager level) to join a fantastic Pharmaceutical company based in Lausanne, Switzerland as they ensure to be compliant with the FDA and EMA laws regarding Clinical Trial Transparency and Disclosure. This will be the first hire in the business within the area, so you'll play a key role in working with a range of teams internally to ensure clinical trial data sharing is compliant with national laws and regulations while making sure privacy and intellectual property is protected. As this is a new area in the industry, our client are willing to take someone from a Clinical Trial Management background who would be interested in making a move into a new and challenging role where you can progress within the company in the future.

Ideally, 3 days office working is required for this position in Lausanne and also, relocators from the UK & EU are welcome. What's on offer? A flexible basic salary (mid manager level for Switzerland) + bonus + relocation assistance + much more.

**Your responsibilities**:

- Work with program and study teams to define strategy for clinical trial transparency on program and study level
- Coordinate **or perform **redaction of documents for disclosure on public registries (e.g. clinicaltrials.gov, EU registry) according to national regulations.
- Lead tracking and update management for public registries to ensure compliance with national regulations.
- Ensure that clinical trial data sharing is compliant with national laws and regulations while ensuring privacy and intellectual property is protected.
- Coordinate preparation of lay person summaries or study results.
- Ensure that company clinical trial website for patients is compliant and coordinate the update with needed functions according to the process.
- Contributes to process improvement by collaborating with internal functions, refining work instructions, training materials, and procedures as needed to build internal company awareness of data privacy and intellectual property.
- Be the responsible GDPR champion for the Clinical Operations team coordinating GDPR related activities.
- Provide support to the Clinical Operations team either to Clinical Trial Coordinators (CTCs) / TMFs specialists team or participate to transversal taskforces on an ad-hoc basis.

**Requirements**:

- A Bachelor's or Master's degree in Sciences or Clinical Operations with at least 5 years working experience within clinical research in the pharmaceutical industry (Sponsor or CRO).
- Strong understanding of data privacy regulations and understanding importance of protecting intellectual property within the pharmaceutical industry.
- Experience in redaction of documents for disclosure as part of Clinical Trials.
- Understanding of national regulations related to Clinical Trials transparency and disclosure for US and EU.
- Experience in trial registration and results reporting in relevant web-based registries (e.g., clinicaltrials.gov, EudraCT).
- Experience in lay persons summaries.
- Excellent communication and project management skills.
- Well organised and with strong collaboration skills.
- Very good written and spoken English skills (C1).

**Benefits**
- International, highly dynamic environment with a long term vision.
- Cross-functional collaboration at the forefront of the most advanced scientific developments in oncology and anti-bacterial industry.
- Exposure to a wide variety of areas and functions within clinical development and the pharmaceutical industry
- Participation in a company where innovation, people and entrepreneurship are the fundamental keys to success.
- Proud to be an Equal-Pay certified, we ensure offering to all our employees the same opportunities.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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