Avalo Therapeutics
Director Data Management
Chesterbrook, PA · Director
Sponsorship not specifiedDetected 27 days ago
GCPStatisticsHRClinical TrialsFDA RegulatoryPharmacovigilanceLeadershipBiostatisticsRegulatory Affairs
About the role
- The Director Clinical Data Management provides strategic and operational leadership for all clinical data management activities across Avalo's clinical development portfolio.
- Provide leadership and oversight of CROs and technology vendors responsible for data management deliverables.
- Ensure quality, integrity, consistency, and timely availability of clinical trial data.
Responsibilities
- Lead and oversee all clinical data management activities across multiple clinical studies and development programs.
- Develop and implement data management strategies that support clinical, regulatory, and business objectives.
- Drive risk-based data review and quality management practices.
- Support regulatory inspections and audits.
- Build scalable data management processes, standards, and SOPs as the organization grows.
Requirements
- Experience with modern EDC systems such as Medidata Rave, Veeva CDMS, Oracle, or equivalent platforms.
Nice to have
- BS/BA degree in Life Sciences, Engineering, Computer Science, Mathematics, Statistics, or related field
- MS/MA degree preferred.
- 12+ (if MS/MA degree) or 15+ (if BS/BA degree) years of clinical data management experience within biotechnology, pharmaceutical, CRO, or related environments.
- 5+ years of people management experience
- Demonstrated experience supporting Phase I-III clinical trials.
- Experience overseeing external data management vendors and CRO partnerships.
Skills
- Experience with risk-based quality management (RBQM)
- Database Build and Validation Documentation
Benefits
- Collaborate closely with Biostatistics, Statistical Programming, Clinical Operations, Clinical Development, Medical Monitoring, Regulatory Affairs, and Pharmacovigilance teams.
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