Director, Clinical Data Management
PTC Therapeutics, Inc.
August 09, 2026
Remote friendly (New Jersey, United States)
United States
Clinical Research and Development
Job Description Summary:
- Director, Clinical Data Management. Candidates local to Warren, NJ strongly preferred for a flexible hybrid model; open to relocation.
Responsibilities (Essential Functions):
- Lead strategic vision for data management; ensure clinical data quality, integrity, consistency, and inspection readiness.
- Oversee CROs and end-to-end data management projects, including EDC database cleaning, reconciliation, SAE reconciliation, and data lock.
- Partner with Clinical Ops, biostatisticians, SAS programmers, and others to design data collection instruments (e.g., eCRFs).
- Support coding review for AEs/medical history/concomitant meds and coordinate medical monitor review/approval.
- Develop data management plans and data review plans; supervise database development and ensure completeness/accuracy/consistency.
- Produce periodic study status reporting (CRF completion, missing pages, query aging, CPT, etc.).
- Interact with external vendors (e.g., labs) for collection/transmittal/transfer of study data.
- Develop/update SOPs/WIs/BPDs; facilitate regulatory submissions and audit/inspection activities.
- Gather clinical system requirements; assess/select data management vendors/systems.
- Mentor team members; manage multiple priorities; may manage direct reports.
Qualifications / Required Skills:
- BS in science/related field + 10+ years relevant experience; strong leadership of data management teams.
- Knowledge of ICH, CDASH, 21 CFR Part 11, FDA; drug development/data operations.
- Medidata or relational DB experience (e.g., Oracle RDC, InForm, Veeva EDC) and data visualization (e.g., Spotfire/J-Review/Business Objects).
- Proficiency in Microsoft Office.
- 25% travel.
Preferred:
- 5+ years Medidata RAVE (EDC, R2DS/RBS, Architect, Coder); CDISC knowledge.
- PL/SQL, SAS, Java, C++ database programming/design; experience with ICH/GxP/Annex 11/GDPR/GAMP and risk-based approaches.
Compensation/Benefits (as stated):
- Expected base salary range: $200,700–$252,600; eligible for short- and long-term incentives and medical/dental/vision/retirement savings plans.
- Director, Clinical Data Management. Candidates local to Warren, NJ strongly preferred for a flexible hybrid model; open to relocation.
Responsibilities (Essential Functions):
- Lead strategic vision for data management; ensure clinical data quality, integrity, consistency, and inspection readiness.
- Oversee CROs and end-to-end data management projects, including EDC database cleaning, reconciliation, SAE reconciliation, and data lock.
- Partner with Clinical Ops, biostatisticians, SAS programmers, and others to design data collection instruments (e.g., eCRFs).
- Support coding review for AEs/medical history/concomitant meds and coordinate medical monitor review/approval.
- Develop data management plans and data review plans; supervise database development and ensure completeness/accuracy/consistency.
- Produce periodic study status reporting (CRF completion, missing pages, query aging, CPT, etc.).
- Interact with external vendors (e.g., labs) for collection/transmittal/transfer of study data.
- Develop/update SOPs/WIs/BPDs; facilitate regulatory submissions and audit/inspection activities.
- Gather clinical system requirements; assess/select data management vendors/systems.
- Mentor team members; manage multiple priorities; may manage direct reports.
Qualifications / Required Skills:
- BS in science/related field + 10+ years relevant experience; strong leadership of data management teams.
- Knowledge of ICH, CDASH, 21 CFR Part 11, FDA; drug development/data operations.
- Medidata or relational DB experience (e.g., Oracle RDC, InForm, Veeva EDC) and data visualization (e.g., Spotfire/J-Review/Business Objects).
- Proficiency in Microsoft Office.
- 25% travel.
Preferred:
- 5+ years Medidata RAVE (EDC, R2DS/RBS, Architect, Coder); CDISC knowledge.
- PL/SQL, SAS, Java, C++ database programming/design; experience with ICH/GxP/Annex 11/GDPR/GAMP and risk-based approaches.
Compensation/Benefits (as stated):
- Expected base salary range: $200,700–$252,600; eligible for short- and long-term incentives and medical/dental/vision/retirement savings plans.