Debiopharm Group™ is a Swiss-headquartered global biopharmaceutical group active in the life science areas of drug development, GMP manufacturing of proprietary drugs, diagnostic tools and investment management. Debiopharm International SA is focused on the development of prescription drugs that target unmet medical needs. The company in-licenses and develops promising drug candidates. The products are commercialized by pharmaceutical out-licensing partners to give access to the largest number of patients worldwide.
For our Biostatistics and Data Management Department, we are building a pipeline for future opportunities as :
Senior Clinical Data Manager
The Senior Clinical Data Manager is accountable for the quality and timelines of all Data Management deliverables for assigned clinical trials, including trials for which data management activities are outsourced to external providers. He/she ensures timely availability of complete, accurate and consistent clinical data to support internal decision making process. He/she is a key member of the clinical study team, and responsible for performing and/or overseeing the set-up, maintenance, control, cleaning and validation of clinical study databases, in compliance with SOPs and regulatory guidelines. He/she works closely with clinical trial managers, Medical directors and Biostatisticians and provides efficient data management support to the study team.
Your main responsibilities:
- Define and manage Clinical Data Management timelines on multiple studies or programs
- 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.
- Scientific or technical education background, ideally university level
- Experience of 5 years minimum in clinical data management, with strong experience using major EDC systems and related tools and technologies.
- Experience of overseeing the set-up, maintenance, control, cleaning and validation of clinical study databases.
- Experience leading data management studies and teams to timely deliver quality databases that meet regulatory requirements.
- Oncology experience is strongly desirable.
- Good planning, organizational and communications skills
- Ability to effectively work and collaborate in a complex matrix organisation.
- Fluent in English, good knowledge of French an asset.
Debiopharm can offer you:
- An international and highly dynamic environment.
- The opportunity to join a successful company, at the forefront of the most advanced scientific developments in the industry.
- The possibility to be in a company in which innovation, people and entrepreneurship are the fundamentals of its success.