Director of Data Management

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee all clinical data management functions across Secretome's clinical development initiatives.

• Formulate and execute data management strategies, standards, processes, and best practices.

• Supervise protocol evaluations, electronic case report form (eCRF) design, database creation, edit check specifications, user acceptance testing, data cleansing, reconciliation, coding, and database locking.

• Manage Contract Research Organizations (CROs), data management vendors, and technology providers to guarantee quality deliverables, adherence to timelines, and budget compliance.

• Create and uphold data governance frameworks to ensure data quality, integrity, traceability, and readiness for inspections.

• Collaborate effectively with Clinical Operations, Clinical Development, Biostatistics, Statistical Programming, Pharmacovigilance, Regulatory Affairs, and Quality teams.

• Lead risk-based data review and quality oversight, including metrics, issue management, and ongoing process enhancements.

• Ensure adherence to ICH-GCP, FDA regulations, 21 CFR Part 11, company Standard Operating Procedures (SOPs), and relevant privacy regulations.

• Assist with regulatory inspections, audits, and submissions to health authorities.

• Develop and maintain data management SOPs, work instructions, templates, and training materials.

• Build and lead a high-performing data management team as the company progresses its clinical pipeline.

⛳️ Requirements

• Bachelor’s degree in Life Sciences, Health Sciences, Computer Science, Biostatistics, Health Informatics, or a related field.

• Over 8 years of progressive experience in clinical data management within biotechnology, pharmaceutical, or CRO settings.

• Proven leadership in managing clinical programs and external data management vendors.

• Strong proficiency in Electronic Data Capture (EDC) systems, database design, data review, coding, reconciliation processes, and database locking activities.

• Familiarity with CDISC standards, MedDRA, and WHODrug.

• Comprehensive understanding of ICH-GCP, FDA regulations, data integrity principles, and clinical trial data standards.

• Exceptional project management, communication, and organizational abilities.

• Capability to excel in a dynamic, high-growth biotechnology environment.

• Advanced degree (MS, MPH, PharmD, or equivalent) is preferred.

• Certification as a Clinical Data Manager (CCDM) is preferred.

• Experience with biologics, cell therapy, regenerative medicine, cardiovascular, or rare disease programs is preferred.

• Experience leading data management activities during regulatory submissions and inspections is preferred.

• Experience in building or scaling data management capabilities within a growing biotech company is preferred.

🏝️ Benefits

• Competitive salary and performance-based incentives.

• Comprehensive health, dental, and vision insurance.

• Generous paid time off and holidays.

• Opportunities for professional development and continuing education.

• Dynamic and collaborative work environment.