Associate Director, Clinical Data Management
PTC Therapeutics, Inc.
August 08, 2026
Remote friendly (New Jersey, United States)
United States
Clinical Research and Development
Associate Director, Clinical Data Management (Warren, NJ area preferred; flexible hybrid; open to relocation).
Responsibilities:
- Lead oversight of clinical data management activities to ensure accurate, consistent clinical databases for analysis/reporting.
- Collaborate with CROs and internal teams to execute data management plans end-to-end.
- Design/develop data collection instruments (eCRFs) and manage database development.
- Oversee coding review (AEs, medical history, concomitant meds) and coordinate medical monitor approval.
- Lead EDC database cleaning, reconciliation (external vendor data), SAE reconciliation, and database lock activities.
- Develop data management and data review plans; ensure data completeness, accuracy, consistency.
- Prepare/distribute periodic study status reports (e.g., CRF completion, missing pages, query aging, CPT).
- Coordinate with vendors (e.g., clinical labs) on collection/transmittal/transfer of study data.
- Develop/update SOPs and documents (WI/BPD) for data collection/handling/review.
- Validate statistical outputs used in final reports; mentor team members; prioritize multiple tasks.
- Partner with Legal/Compliance; support “ONE Team”; contribute to outsourcing strategies/quality DM partner identification.
Qualifications / Required:
- BS in science/related field; 8+ years progressively responsible DM experience in pharma/biotech/CRO/regulatory agency.
- 2nd-line management/functional leadership experience; vendor management (IWRS, Imaging, PRO, databases).
- ICH, CDASH, 21 CFR Part 11, FDA guideline knowledge; drug development/data ops understanding.
- Strong communication, decision-making, influencing, negotiation, and project management.
- Medidata or relational databases (e.g., Oracle RDC, InForm, Veeva EDC) and data visualization tools (e.g., Spotfire/J-Review/Business Objects).
- Microsoft Office proficiency; ability to work in matrix environment.
- 5+ years Medidata RAVE (EDC/R2DS/RBS/Architect) and Medidata RAVE experience.
- CDISC knowledge; regulatory/data standards.
- Travel: 5–15%.
Preferred:
- Experience with PL/SQL, SAS, Java, C++, relational DB design/programming.
Compensation/Benefits (if eligible):
- Expected base salary range: $163,800–$206,200; plus short- and long-term incentives; medical/dental/vision and retirement savings plans.
Responsibilities:
- Lead oversight of clinical data management activities to ensure accurate, consistent clinical databases for analysis/reporting.
- Collaborate with CROs and internal teams to execute data management plans end-to-end.
- Design/develop data collection instruments (eCRFs) and manage database development.
- Oversee coding review (AEs, medical history, concomitant meds) and coordinate medical monitor approval.
- Lead EDC database cleaning, reconciliation (external vendor data), SAE reconciliation, and database lock activities.
- Develop data management and data review plans; ensure data completeness, accuracy, consistency.
- Prepare/distribute periodic study status reports (e.g., CRF completion, missing pages, query aging, CPT).
- Coordinate with vendors (e.g., clinical labs) on collection/transmittal/transfer of study data.
- Develop/update SOPs and documents (WI/BPD) for data collection/handling/review.
- Validate statistical outputs used in final reports; mentor team members; prioritize multiple tasks.
- Partner with Legal/Compliance; support “ONE Team”; contribute to outsourcing strategies/quality DM partner identification.
Qualifications / Required:
- BS in science/related field; 8+ years progressively responsible DM experience in pharma/biotech/CRO/regulatory agency.
- 2nd-line management/functional leadership experience; vendor management (IWRS, Imaging, PRO, databases).
- ICH, CDASH, 21 CFR Part 11, FDA guideline knowledge; drug development/data ops understanding.
- Strong communication, decision-making, influencing, negotiation, and project management.
- Medidata or relational databases (e.g., Oracle RDC, InForm, Veeva EDC) and data visualization tools (e.g., Spotfire/J-Review/Business Objects).
- Microsoft Office proficiency; ability to work in matrix environment.
- 5+ years Medidata RAVE (EDC/R2DS/RBS/Architect) and Medidata RAVE experience.
- CDISC knowledge; regulatory/data standards.
- Travel: 5–15%.
Preferred:
- Experience with PL/SQL, SAS, Java, C++, relational DB design/programming.
Compensation/Benefits (if eligible):
- Expected base salary range: $163,800–$206,200; plus short- and long-term incentives; medical/dental/vision and retirement savings plans.