Head of Clinical Data Strategy & Delivery

Secretome Therapeutics, Inc.; United States; Remote; USD 170,000 - 210,000; Full time

Job summary

Secretome Therapeutics, Inc. in Plano, Texas, seeks a Director of Data Management to lead strategy and execution of clinical data management across our development portfolio.

The role focuses on data quality, integrity, and timely delivery while building scalable processes and standards to support growth. You will collaborate with Clinical Operations, Biostatistics, Safety, Regulatory Affairs, and external vendors to ensure successful studies and regulatory submissions, driving continuous

Qualifications

• Bachelor’s degree in Life Sciences or related discipline.
• 8+ years of progressive clinical data management experience.
• Experience leading external data management vendors.
• Strong expertise in EDC systems, data review, coding, reconciliation, and database lock.
• 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.

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 CROs, data management vendors, and technology providers to ensure quality deliverables, timeline adherence, and budget compliance.
• Establish and maintain data governance frameworks ensuring data quality, integrity, traceability, and inspection readiness.
• Collaborate with Clinical Operations, Biostatistics, 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 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.

Skills

Leadership

Project management

Communication

Organizational skills

Education

Bachelor’s degree in Life Sciences or related

MS/PhD preferred

Tools

EDC systems

Database design

CDISC standards (knowledge)

Job description

Secretome Therapeutics, Inc. in Plano, Texas, seeks a Director of Data Management to lead strategy and execution of clinical data management across our development portfolio.

The role focuses on data quality, integrity, and timely delivery while building scalable processes and standards to support growth. You will collaborate with Clinical Operations, Biostatistics, Safety, Regulatory Affairs, and external vendors to ensure successful studies and regulatory submissions, driving continuous