Debiopharm Group™ (Debiopharm) is a Swiss-based biopharmaceutical group of four companies active in drug development, GMP manufacturing of proprietary drugs, diagnostics, and investments. Debiopharm International SA searches, evaluates and in-licenses promising drug candidates for development. Towards the end of the development process, the products are licensed out to pharmaceutical companies for world-wide marketing and sales.
For our Biostatistics and Data Management Department, we are looking for a :
Senior Clinical Data Manager - 1 year assignment
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.
- 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 leading data management studies and teams to timely deliver quality databases that meet regulatory requirements
- Good planning, organizational and communications skills
- Ability to effectively work and collaborate in a complex matrix organisation
Debiopharm International SA
CP 5911 /Chemin Messidor 5-7