P2265 - Senior Clinical Data Manager

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.

Here: https://apply.workable.com/debiopharm-group-sa/

For our Biostats and Data Management Department organization based at our Headquarters in Lausanne, we are looking for a

Senior Clinical Data Manager

Your responsibilities will be but not limited to:

• Define and manage Clinical Data Management timelines on multiple studies or programs in Oncology and Anti-infectives diseases
• Coordinate/perform CDM activities for assigned studies/programs, including eCRF design, EDC system set up, user acceptance testing, users training, database release, data review and query generation and data coding
• Prepare data management plans, data validation plans and other study specific procedures and guidelines in compliance with standard processes and SOPs
• Ensure appropriate study specific training is provided to assigned study teams and documented
• Ensure ongoing and timely data capture and data cleaning, including external data sources
• Provide/coordinate data management support to study teams to support timely and ongoing data review and monitoring
• Ensure study timelines are met and data quality is according to high industry standards
• Lock, transfer, and archive databases
• Ensure adherence to GCP, regulatory guidelines, standard processes, and SOPs

Requirements

• Master Degree in Sciences, combined with at least 5 years professional experience in clinical data management in the pharmaceutical industry,
• A strong experience using major EDC systems and related tools and technologies is required
• Strong experience leading data management studies and teams to timely deliver quality databases that meet regulatory requirements within Sponsor
• Good planning, organizational and communications skills
• Team player, you look for a matrix work organization and international work environment
• Fluent in English (C1), French is an asset

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

The use of external staffing agencies or recruiters requires prior approval from our Human Resources Department. The Human Resources Department at Debiopharm requests external staffing agencies or recruiters not to contact Debiopharm employees or members of the Board of Directors directly in an attempt to present candidates.

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.

Debiopharm will not accept unsolicited resumes from any source other than candidates themselves for either current or future positions.