Director, Clinical Data Management
PTC Therapeutics, Inc.
June 27, 2026
Remote friendly (New Jersey, United States)
United States
Clinical Research and Development
Job Description Summary:
- Director, Clinical Data Management provides strategic and operational leadership and oversight of clinical data management to ensure quality, integrity, consistency, and inspection readiness of clinical databases for analysis, reporting, and regulatory submissions.
- Candidates local to Warren, NJ preferred for a flexible hybrid model; relocation open.
Essential Functions (Responsibilities):
- Ensure study data meets objectives and quality standards.
- Lead DM vision; provide functional oversight of CROs and end-to-end DM projects.
- Partner with Clinical Operations, biostatisticians, and SAS programmers to design data collection instruments (e.g., eCRFs).
- Oversee coding review (AEs, medical history, concomitant meds) and medical monitor approval.
- Lead database cleaning in EDC, data/SAE reconciliation, and database lock activities.
- Develop DM and data review plans; supervise database development and processing.
- Produce periodic study status reports (CRF completion, missing pages, query aging, clean patient tracker).
- Coordinate vendor interactions (e.g., labs), maintain SOPs/WIs/BPDs, and support audits/inspections.
- Gather system requirements, assess/select DM vendors/systems, validate statistical outputs.
- Mentor team members; manage multiple priorities.
Knowledge/Skills/Abilities Required:
- BS in science (or related); 10+ years progressively responsible pharma/biotech/CRO/regulatory experience.
- Leadership in DM teams; vendor management; experience with IWRS, imaging, ePRO/eCOA.
- ICH, CDASH, 21 CFR Part 11, FDA; drug development/data operations.
- Medidata or relational DBs (Oracle RDC/InForm/Veeva EDC); data visualization tools; MS Office.
Preferred:
- 5+ years Medidata RAVE (EDC/R2DS-RBS/Architect/Coder); CDISC; PL/SQL/SAS/Java/C++.
- Experience with ICH/GxP/Annex 11/GDPR/GAMP; risk-based approach.
Travel: 25%.
Compensation/Benefits (as stated):
- Expected base salary range: $200,700–$252,600; eligibility for short-/long-term incentives and medical/dental/vision/retirement savings plans.
- Director, Clinical Data Management provides strategic and operational leadership and oversight of clinical data management to ensure quality, integrity, consistency, and inspection readiness of clinical databases for analysis, reporting, and regulatory submissions.
- Candidates local to Warren, NJ preferred for a flexible hybrid model; relocation open.
Essential Functions (Responsibilities):
- Ensure study data meets objectives and quality standards.
- Lead DM vision; provide functional oversight of CROs and end-to-end DM projects.
- Partner with Clinical Operations, biostatisticians, and SAS programmers to design data collection instruments (e.g., eCRFs).
- Oversee coding review (AEs, medical history, concomitant meds) and medical monitor approval.
- Lead database cleaning in EDC, data/SAE reconciliation, and database lock activities.
- Develop DM and data review plans; supervise database development and processing.
- Produce periodic study status reports (CRF completion, missing pages, query aging, clean patient tracker).
- Coordinate vendor interactions (e.g., labs), maintain SOPs/WIs/BPDs, and support audits/inspections.
- Gather system requirements, assess/select DM vendors/systems, validate statistical outputs.
- Mentor team members; manage multiple priorities.
Knowledge/Skills/Abilities Required:
- BS in science (or related); 10+ years progressively responsible pharma/biotech/CRO/regulatory experience.
- Leadership in DM teams; vendor management; experience with IWRS, imaging, ePRO/eCOA.
- ICH, CDASH, 21 CFR Part 11, FDA; drug development/data operations.
- Medidata or relational DBs (Oracle RDC/InForm/Veeva EDC); data visualization tools; MS Office.
Preferred:
- 5+ years Medidata RAVE (EDC/R2DS-RBS/Architect/Coder); CDISC; PL/SQL/SAS/Java/C++.
- Experience with ICH/GxP/Annex 11/GDPR/GAMP; risk-based approach.
Travel: 25%.
Compensation/Benefits (as stated):
- Expected base salary range: $200,700–$252,600; eligibility for short-/long-term incentives and medical/dental/vision/retirement savings plans.