Director, Clinical Data Management — Hybrid Leader (EDC)

Regulatory Jobs; New Jersey; Hybrid; USD 201,000 - 253,000; Full time

Job summary

PTC Therapeutics is seeking a Director of Clinical Data Management in the Warren, NJ area with a strong track record in leading data management teams and overseeing CROs. The role drives strategic vision for data management, ensures regulatory compliance, and collaborates with biostatistics, Clinical Operations, and QA to enable high-quality data for regulatory submissions.

The position supports a hybrid work model, with relocation openness, and requires extensive experience with DM systems

Qualifications

• Bachelor’s degree in science; 10+ years in pharma/biotech data management
• Proven leadership of data management teams
• Experience with IWRS, imaging, ePRO/eCOA
• Strong knowledge of regulatory standards (FDA/ICH/CDISC/21 CFR Part 11)
• Excellent communication and project management skills

Responsibilities

• Provide strategic and operational leadership of data management activities.
• Oversee CROs to execute data management plans and projects from start to finish.
• Lead development of data management plans, data review plans, and QA/documentation.
• Coordinate data collection instruments (e.g., eCRFs) for statistical analysis.
• Ensure regulatory compliance and readiness for submissions and audits.
• Mentor team members and collaborate with cross-functional stakeholders.

Skills

Leadership of DM team

Vendor management

IWRS/imaging/ePRO/eCOA

Regulatory standards knowledge (FDA/IC

Education

Bachelor's degree in science

Tools

Medidata RAVE (EDC)

Oracle RDC

InForm

Veeva EDC

Job description

PTC Therapeutics is seeking a Director of Clinical Data Management in the Warren, NJ area with a strong track record in leading data management teams and overseeing CROs. The role drives strategic vision for data management, ensures regulatory compliance, and collaborates with biostatistics, Clinical Operations, and QA to enable high-quality data for regulatory submissions.

The position supports a hybrid work model, with relocation openness, and requires extensive experience with DM systems