P2306 - Clinical Operations Transparency Lead

Vor 6 Tagen

Lausanne, Schweiz Debiopharm Vollzeit

Description

Debiopharm is an independent biopharmaceutical company based in Switzerland with an ongoing commitment to research in oncology and infectious diseases in order to improve patient outcomes and quality of life. Our main activities include drug development, drug manufacturing and digital health investment. Debiopharm International SA aims to develop innovative therapies that target high unmet medical needs. Our unique “development only” business model allows us to act as a bridge between disruptive discovery products and patient access in international markets. We first identify high-potential compounds for in-licensing, clinically demonstrate their safety and efficacy and then select large pharmaceutical commercialization partners to maximize patient access globally.

At Debiopharm you will be at the forefront of the fight against cancer and infectious diseases, and you will have the opportunity to work on new innovative medicines for patients. Efficiency is our mode of action, saving lives our collective target.

For our Clinical Operations organization based at our Headquarters in Lausanne, we are looking for a

Clinical Operations, Transparency Lead

In this newly created role, you will be responsible for ensuring that clinical trial documents provided to the FDA and EMA are redacted according to privacy laws and business needs and the clinical trial databases and company website are kept updated. You will also be the GDPR representative for clinical Operations and responsible for ensuring compliance with GDPR regulations in collaboration with the Data Processing Officer (DPO) at Debiopharm.

**Your responsibilities will be but not limited to**:
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 and collaborating with the Debiopharm DPO
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 organized 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

Submission of unsolicited resumes in advance of an agreement between the Human Resources Department and the external staffing agency or recruiter does not create any implied obligation on the part of Debiopharm.

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