Debiopharm Group™ is a Swiss-headquartered global biopharmaceutical group including five companies 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 Data Management Department based in Lausanne we are looking for a :
Manager Clinical Data Management
To provide functional expertise and leadership while delivering Data Management (DM) expertise to clinical projects and studies.
Primarily responsible for defining and implementing Data Management standards, driving compliance and developing innovative solutions for collecting and delivering high quality clinical data, you will manage a team of Clinical Data Managers and be accountable for the quality and timelines of all DM deliverables for clinical programs and studies, including studies for which DM activities are outsourced to CRO partners;
and work in close collaboration with Biostatistics, Clinical Operations, Data Science and Clinical Development.
Your main responsibilities :
Ensures quality of Clinical Data Management deliverables by consistently applying DM standards and driving compliance and performance.
Manages a team of Clinical Data Managers and perform resource planning for their assigned studies.
Responsible for the acquisition, management and development of talent. Provides mentoring and support to Clinical Data Management staff.
Oversees the production of Data Management deliverables (e.g., database programming, data cleaning, database lock) for study reports and submission.
Provides guidance to vendors around project standards, DM conventions / specifications and ensures efficient and integrated project reporting strategies, metrics, and KPIs
Communicates effectively with stake holders and coordinates with Translational Medicine, Therapeutic Areas, CDM, Clinical Operations, Biostatistics, IT, External Service Providers and CROs, as applicable, in order to address major and / or escalated project / study issues
Contribute as needed to the review and approval of study documents
Support the development of strategic plans aligned with business goals
Support the preparation of project budgets and management of financial performance.
Provide input / leads internal process improvement and development of standards and adopting procedures to new technologies and regulatory requirements.
Ensure adherence to GCP, regulatory guidelines, standard processes, and SOPs.
Support internal as well as vendor audits to ensure compliance with SOPs and industry standards.
Your profile :
MSc / BSc in life sciences or related field
Minimum of 7 years of Data Management experience in pharmaceutical or CRO industry and strong performance track record, combined with at least 2 years of people management.
Advanced knowledge of the drug development process, clinical trial methodology, and familiarity with global regulatory requirements, including electronic data submissions
Understands software development and validation methodologies and appropriately applies those methodologies.
Ability to work successfully within cross-functional teams, developing and maintaining successful partnerships
Demonstrated ability to adapt quickly to changing needs within the organization
Communicates proactively and effectively, excellent verbal and written communications skills
Excellent written and verbal skills in English
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.