Associate Director, Clinical Data Management
PTC Therapeutics, Inc.
August 30, 2026
Remote friendly (New Jersey, United States)
United States
Clinical Research and Development
Job Description Summary:
- The Associate Director, Clinical Data Management provides leadership and oversight of data management activities to ensure accuracy and consistency of clinical databases for analysis and reporting. Develop plans for EDC/system utilization and help define Sponsor processes for maintaining clinical data and QA/QC documentation. Supports adherence to relevant regulatory requirements and SOPs.
Essential Functions (Primary duties/responsibilities):
- Ensure data meets study objectives and quality standards.
- Assist with strategic vision for the data management (DM) group.
- Collaborate with CROs to execute data management plans; manage DM projects end-to-end.
- Design/develop data collection instruments (e.g., eCRFs) with Clinical Operations, biostatisticians, SAS programmers, etc.
- Oversee coding review for adverse events, medical history, and concomitant medications; coordinate medical monitor review/approval.
- Lead database cleaning in EDC, data reconciliation, SAE reconciliation, and lock activities.
- Develop data management and data review plans; supervise database development; ensure completeness/accuracy/consistency.
- Prepare/distribute periodic study status reports (CRF completion, missing pages, query aging, CPT, etc.).
- Lead vendor interactions for collection/transmittal/transfer of study data.
- Develop/update SOPs/WIs/BPDs; participate in clinical review/validation of statistical outputs.
- Mentor teams; manage multiple priorities; drive collaboration (including Legal/Compliance).
Knowledge/Skills/Abilities Required:
- BS in science/related field; 8+ years progressively responsible experience in pharma/biotech/CRO/Regulatory Agency (data collection/assimilation).
- Second-line management/functional leadership; vendor management experience (IWRS, Imaging, PRO, databases).
- ICH, CDASH, 21 CFR Part 11, FDA guidelines; drug development process and data operations.
- Communication, influencing, negotiation, and project management skills.
- Medidata or relational databases (Oracle RDC, InForm, Veeva EDC) and data visualization tools (Spotfire, J-Review, Business Objects).
- Microsoft Office proficiency; ability to work in a fast-paced matrix environment.
- Preferred: 5+ years Medidata RAVE (EDC, R2DS/RBS, Architect) and experience with PL/SQL, SAS, Java, C++.
- Travel: 5–15%.
Benefits (explicitly stated):
- Base salary range: $163,800–$206,200; eligible for short-/long-term incentives; medical/dental/vision and retirement savings plans.
- The Associate Director, Clinical Data Management provides leadership and oversight of data management activities to ensure accuracy and consistency of clinical databases for analysis and reporting. Develop plans for EDC/system utilization and help define Sponsor processes for maintaining clinical data and QA/QC documentation. Supports adherence to relevant regulatory requirements and SOPs.
Essential Functions (Primary duties/responsibilities):
- Ensure data meets study objectives and quality standards.
- Assist with strategic vision for the data management (DM) group.
- Collaborate with CROs to execute data management plans; manage DM projects end-to-end.
- Design/develop data collection instruments (e.g., eCRFs) with Clinical Operations, biostatisticians, SAS programmers, etc.
- Oversee coding review for adverse events, medical history, and concomitant medications; coordinate medical monitor review/approval.
- Lead database cleaning in EDC, data reconciliation, SAE reconciliation, and lock activities.
- Develop data management and data review plans; supervise database development; ensure completeness/accuracy/consistency.
- Prepare/distribute periodic study status reports (CRF completion, missing pages, query aging, CPT, etc.).
- Lead vendor interactions for collection/transmittal/transfer of study data.
- Develop/update SOPs/WIs/BPDs; participate in clinical review/validation of statistical outputs.
- Mentor teams; manage multiple priorities; drive collaboration (including Legal/Compliance).
Knowledge/Skills/Abilities Required:
- BS in science/related field; 8+ years progressively responsible experience in pharma/biotech/CRO/Regulatory Agency (data collection/assimilation).
- Second-line management/functional leadership; vendor management experience (IWRS, Imaging, PRO, databases).
- ICH, CDASH, 21 CFR Part 11, FDA guidelines; drug development process and data operations.
- Communication, influencing, negotiation, and project management skills.
- Medidata or relational databases (Oracle RDC, InForm, Veeva EDC) and data visualization tools (Spotfire, J-Review, Business Objects).
- Microsoft Office proficiency; ability to work in a fast-paced matrix environment.
- Preferred: 5+ years Medidata RAVE (EDC, R2DS/RBS, Architect) and experience with PL/SQL, SAS, Java, C++.
- Travel: 5–15%.
Benefits (explicitly stated):
- Base salary range: $163,800–$206,200; eligible for short-/long-term incentives; medical/dental/vision and retirement savings plans.