Manager Clinical Data Management
A fantastic opportunity has arisen for Manager Clinical Data Management. To provide functional expertise and leadership while delivering Data Management (DM) expertise to clinical projects and studies.
- 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.
Skills and Requirements
- 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.
- 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
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical and medical device companies.