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Job Description
Contact:
Neisha Camacho/Terra Parsons - teamnt@penfieldsearch.com No 3rd party candidates We are partnering with a growing biotech organization seeking a Clinical Data Manager to support ongoing and upcoming clinical programs across multiple Programs This role will sit within a cross-functional clinical development team and support end-to-end data management activities, with a strong focus on execution, quality, and collaboration. The ideal candidate brings solid hands-on data management experience, with exposure to Phase
II & III
trials in a fast-paced biotech environment. Key Responsibilities Support clinical data management activities across studies from start-up through database lock Partner with CROs and vendors to ensure high-quality, timely data delivery Collaborate cross-functionally with Clinical, Biostatistics, Programming, and Medical teams on data collection and review strategies Contribute to development and review of key deliverables, including: Data Management Plans (DMPs) eCRF design and completion guidelines Edit checks and query logic User Acceptance Testing (UAT) Data review and cleaning processes Perform ongoing data review and support query management to ensure data quality and consistency Support implementation of data standards and process improvements Assist with inspection readiness and ensure compliance with regulatory requirements and industry standards Qualifications BS in a scientific or clinical discipline ~5-8 years of clinical data management experience within biotech, pharma, or CRO environments Hands-on experience with EDC systems (e.g., Medidata Rave, Oracle, Veeva) Working knowledge of CDISC standards (SDTM/ADaM) and downstream data usage Experience supporting Phase II or III clinical trials; CNS experience is a plus Exposure to CRO/vendor oversight Understanding of data structures and dictionaries (e.g., MedDRA, WHODrug) Strong collaboration skills and ability to work cross-functionally Detail-oriented, proactive, and comfortable in a dynamic environment