Responsible for planning, implementing and managing Clinical Data Management (CDM) activities across ReCor’s global clinical program as well as recognizing and supporting the needs of other functions including Regulatory, Medical & Scientific Affairs.
Responsibilities includes managing a global CDM team, EDC database and technology selections, vendor management, data collection and review, process improvement and ensuring that quality standards are maintained.
Knowledge, Experience, And Skills:
- Experience working in cross-functional team-oriented environments and capability of working on multiple projects simultaneously
- Expert level understanding of ISO GCP, GCDMP, 21CFR Part 11 and other global regulatory requirements as they pertain to data management.
- Working knowledge of data protection requirements including GDPR preferred
- Working knowledge of EDC systems (e.g. RAVE, Medrio, InForm, etc.)
- Working knowledge of SDTM/C-DASH
- Knowledge and experience with MedDRA, WHODrug and other Thesaurus-based classifications
- Medical Device Industry experience across all stages of global clinical studies
- Knowledge of CDISC/SDTM.
- Prefer experience or working knowledge of SAS, R, Python and/or SQL programming
- Prefer experience or working knowledge of data reporting tools such as Spotfire, JMP Clinical, Tableau
- Qualified candidates must have an appropriate BA/BSc degree from an accredited college or university; Higher degree (Masters; PhD) in life sciences, or related field preferred.
- Minimum of 10 years in CDM experience in relevant Pharma/Medical Device/CRO setting
- Experience with CDISC therapeutic area standards a plus
- Proficiency in Microsoft Office tools