Director of Data Management

RA Cap; Plano (TX); Híbrido; USD 180.000 - 240.000; Jornada completa

Descripción de la vacante

Secretome Therapeutics, a Plano-based biotechnology company, seeks a Director of Data Management to lead clinical data management strategy across its development portfolio. The role partners with Clinical Operations, Biostatistics, Regulatory Affairs, and external vendors to assure data integrity, study execution, and regulatory submissions.

Responsibilities include designing eCRF, data governance, protocol review, database lock, and vendor oversight, ensuring ICH-GCP and FDA alignment in a

Formación

• 8+ years of progressive clinical data management experience within biotechnology, pharmaceutical, or CRO environments.
• Demonstrated leadership of clinical programs and external data management vendors.
• Strong expertise in eCRF design, database development, edit checks, and database lock.
• Working knowledge of CDISC standards, MedDRA, and WHODrug; thorough ICH-GCP and FDA data standards understanding.

Responsabilidades

• Lead all clinical data management activities across Secretome's development programs.
• Develop and implement data management strategies, standards, processes, and best practices.
• Oversee protocol review, eCRF design, database development, edit check specs, UAT, data cleaning, and locking.
• Manage CROs, data management vendors, and technology providers to ensure quality and timelines.
• Establish and maintain data governance frameworks ensuring quality, traceability, and inspection readiness.
• Collaborate with Clinical Operations, Biostatistics, Regulatory, and QA teams.
• Drive risk-based data review and continuous process improvement.
• Ensure compliance with ICH-GCP, FDA regulations, 21 CFR Part 11, and privacy requirements.
• Support regulatory inspections and health authority submissions.
• Develop SOPs, work instructions, templates, and training materials.
• Build and lead a high-performing data management function.

Conocimientos

Clinical data management leadership

EDC systems

Database design & data review

CDISC standards

MedDRA & WHODrug

ICH-GCP & FDA regulations

Project management

Communication skills

Educación

Bachelor's degree in Life Sciences, Health Sciences, Computer Science, Biostatistics, Health Informatics, or a related discipline

Advanced degree (MS, MPH, PharmD, or equivalent)

CCDM certification

Descripción del empleo

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.

About the role

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.

What you'll do

• 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, traceability, and inspection readiness.
• Collaborate closely with Clinical Operations, Biostatistics, Statistical Programming, Safety, Regulatory Affairs, and Quality teams to support study milestones and submissions.
• Drive risk-based data review and quality oversight activities, including metrics, issue management, and continuous process improvement.
• Ensure compliance with ICH-GCP, FDA regulations, 21 CFR Part 11, company SOPs, and applicable privacy requirements.
• Support regulatory inspections, audits, and health authority submissions.
• Develop and maintain data management SOPs, work instructions, templates, and training materials.
• Build and lead a high-performing data management function as the company advances its clinical pipeline.

Qualifications

Required Qualifications

• Bachelor's degree in Life Sciences, Health Sciences, Computer Science, Biostatistics, Health Informatics, or a related discipline.
• 8+ years of progressive clinical data management experience within biotechnology, pharmaceutical, or CRO environments.
• Demonstrated leadership of clinical programs and external data management vendors.
• Strong expertise in EDC systems, database design, data review, coding, reconciliation processes, and database lock activities.
• Working knowledge of CDISC standards, MedDRA, and WHODrug.
• Thorough understanding of ICH-GCP, FDA regulations, data integrity principles, and clinical trial data standards.
• Excellent project management, communication, and organizational skills.
• Ability to thrive in a fast-paced, high-growth biotechnology environment.

Preferred Qualifications

• Advanced degree (MS, MPH, PharmD, or equivalent).
• Certified Clinical Data Manager (CCDM) certification.
• Experience supporting biologics, cell therapy, regenerative medicine, cardiovascular, or rare disease programs.
• Experience leading data management activities through regulatory submissions and inspections.
• Experience building or scaling data management capabilities within an emerging biotech company.