Data Management Team Lead

Role: Data Management Lead

Remote

Duration: 6+ Months


Key Responsibilities:

  • Data Management Leadership: Serve as the primary data management point of contact for the DMD program, including the pivotal Phase 3 trial and other related studies.
  • Expectation Readiness: Lead efforts to ensure data is audit- and submission-ready, aligning closely with Clinical Operations, Regulatory, Biostatistics, and Medical Writing.
  • Operational Oversight: Support ongoing operational activities including CRF development, EDC system setup and validation, data cleaning, query resolution, and database lock.
  • Vendor Management: Collaborate with and oversee external data vendors (e.g., CROs, EDC providers, central labs) to ensure high-quality data deliverables and compliance with timelines.
  • Cross-functional Collaboration: Work closely with cross-functional teams (Clinical, Safety, Regulatory, Biometrics, and Quality Assurance) to align data strategy with program goals.
  • Process Improvement: Identify and implement data management process improvements and best practices aligned with ICH-GCP, CDISC, and regulatory expectations.
  • Documentation & Compliance: Ensure proper documentation and compliance with internal SOPs, regulatory guidelines, and audit requirements.


Qualifications:

  • Bachelor’s degree in a life science, health-related, or technical field; advanced degree preferred.
  • 8+ years of clinical data management experience in the biotech/pharmaceutical industry, with at least 3 years in a lead role.
  • Proven track record supporting late-phase (preferably Phase 3) clinical trials, ideally in neuromuscular or rare diseases.
  • Deep understanding of CDISC/CDASH, eCRF design, EDC systems (e.g., Medidata Rave, Veeva), and data standards.
  • Experience preparing data for regulatory submissions (e.g., NDA, BLA).
  • Strong problem-solving, organizational, and project management skills.
  • Excellent communication and leadership skills with a collaborative mindset.


Preferred Qualifications:

  • Experience in rare disease and/or paediatric trials.
  • Familiarity with regulatory inspection readiness and data integrity expectations.
  • Prior involvement in DMD or other neuromuscular disease programs.
  • Experience with data infrastructure and analysis platforms, elluminate preferred