Director of Data Management
About the role
Secretome Therapeutics is a clinical-stage biotechnology company based in Plano, Texas, developing novel therapies derived from neonatal cardiac progenitor cells (nCPC). The Company's lead product candidate, STM-01, is a cellular therapy designed to modulate inflammatory and fibrotic pathways and support myocardial function in Duchenne Muscular Dystrophy (DMD) and Heart Failure with Preserved Ejection Fraction (HFpEF). Secretome is also advancing STM-21, a secretome-based therapeutic currently in preclinical development, and other novel nCPC-based products. Secretome Therapeutics is seeking an experienced and highly motivated Director of Data Management to lead the strategy, execution, and oversight of clinical data management activities across our development portfolio. This individual will be responsible for ensuring the quality, integrity, completeness, and timely delivery of clinical trial data while building scalable processes and standards to support the company's growth. The Director of Data Management will serve as a key cross-functional leader, partnering with Clinical Operations, Clinical Development, Biostatistics, Statistical Programming, Pharmacovigilance, Regulatory Affairs, and external vendors to ensure the successful execution of clinical studies and regulatory submissions.
Responsibilities
- Lead all clinical data management activities across Secretome's clinical development programs.
- Develop and implement data management strategies, standards, processes, and best practices to support study execution and regulatory compliance.
- Oversee protocol review, eCRF design, database development, edit check specifications, user acceptance testing, data cleaning, reconciliation activities, coding, and database lock.
- Manage and oversee CROs, data management vendors, and technology providers to ensure quality deliverables, timeline adherence, and budget compliance.
- Establish and maintain data governance frameworks that ensure data quality, integrity, trace