Associate Director, Clinical Data Management
PTC Therapeutics, Inc.
June 26, 2026
Remote friendly (New Jersey, United States)
United States
Clinical Research and Development
Associate Director, Clinical Data Management
Candidates local to the Warren, NJ area are strongly preferred for a flexible hybrid work model; relocating to the area is welcome.
Responsibilities:
- Lead/oversee data management activities to ensure accurate, consistent clinical databases for analysis/reporting.
- Develop and implement data management vision; collaborate with CROs on data management plans and projects.
- Design data collection instruments (e.g., eCRFs); oversee coding review (AEs, medical history, concomitant meds) and medical monitor coding approval.
- Lead EDC database cleaning, data reconciliation, SAE reconciliation, and database lock activities.
- Develop data review plans; supervise database development; ensure completeness/accuracy/consistency.
- Produce/distribute periodic study status reports (CRF completion, missing pages, query aging, CPT, etc.).
- Coordinate with cross-functional teams and provide feedback to CRAs; manage vendor interactions (e.g., labs).
- Develop/update SOPs, working instructions, and best practices for data collection/handling/review.
- Validate statistical outputs used in final reports; mentor team members; manage multiple priorities.
- Support legal/compliance collaboration; contribute to outsourcing strategy and vendor/partner qualification.
Qualifications/Skills:
- BS in science/related field + 8+ years progressive experience in pharma/biotech/CRO/regulatory agency (data collection/assimilation).
- Second-line management/functional leadership; vendor management experience (IWRS, Imaging, PRO, databases).
- Knowledge of ICH, CDASH, 21 CFR Part 11, and FDA guidance; drug development data operations.
- Technical: Medidata or relational databases (Oracle RDC/InForm/Veeva EDC); visualization (Spotfire/J-Review/Business Objects); MS Office.
- Medidata RAVE: 5+ years (RAVE EDC, R2DS/RBS, Architect). CDISC knowledge preferred.
- Preferred: PL/SQL, SAS, Java, C++.
- Travel: 5–15%.
Compensation/Benefits (as stated): Base salary $163,800–$206,200; eligible for short/long-term incentives and medical/dental/vision/retirement plans.
Candidates local to the Warren, NJ area are strongly preferred for a flexible hybrid work model; relocating to the area is welcome.
Responsibilities:
- Lead/oversee data management activities to ensure accurate, consistent clinical databases for analysis/reporting.
- Develop and implement data management vision; collaborate with CROs on data management plans and projects.
- Design data collection instruments (e.g., eCRFs); oversee coding review (AEs, medical history, concomitant meds) and medical monitor coding approval.
- Lead EDC database cleaning, data reconciliation, SAE reconciliation, and database lock activities.
- Develop data review plans; supervise database development; ensure completeness/accuracy/consistency.
- Produce/distribute periodic study status reports (CRF completion, missing pages, query aging, CPT, etc.).
- Coordinate with cross-functional teams and provide feedback to CRAs; manage vendor interactions (e.g., labs).
- Develop/update SOPs, working instructions, and best practices for data collection/handling/review.
- Validate statistical outputs used in final reports; mentor team members; manage multiple priorities.
- Support legal/compliance collaboration; contribute to outsourcing strategy and vendor/partner qualification.
Qualifications/Skills:
- BS in science/related field + 8+ years progressive experience in pharma/biotech/CRO/regulatory agency (data collection/assimilation).
- Second-line management/functional leadership; vendor management experience (IWRS, Imaging, PRO, databases).
- Knowledge of ICH, CDASH, 21 CFR Part 11, and FDA guidance; drug development data operations.
- Technical: Medidata or relational databases (Oracle RDC/InForm/Veeva EDC); visualization (Spotfire/J-Review/Business Objects); MS Office.
- Medidata RAVE: 5+ years (RAVE EDC, R2DS/RBS, Architect). CDISC knowledge preferred.
- Preferred: PL/SQL, SAS, Java, C++.
- Travel: 5–15%.
Compensation/Benefits (as stated): Base salary $163,800–$206,200; eligible for short/long-term incentives and medical/dental/vision/retirement plans.