Director, Clinical Data Strategy & Operations

RA Cap; Plano (TX); Hybrid; USD 180,000 - 240,000; Full time

Job summary

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

Qualifications

• 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.

Responsibilities

• 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.

Skills

Clinical data management leadership

EDC systems

Database design & data review

CDISC standards

MedDRA & WHODrug

ICH-GCP & FDA regulations

Project management

Communication skills

Education

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

Job description

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