Associate Director, Clinical Data Management - Strategy Lead

PTC Therapeutics, Inc; New Jersey; Hybrid; USD 164,000 - 206,000; Full time

Job summary

PTC Therapeutics, Inc. is seeking an Associate Director, Clinical Data Management to provide leadership over data management activities for clinical databases, ensuring accuracy and regulatory compliance. Based in Warren, NJ with a flexible hybrid work model.

You will lead DM plans, coordinate with CROs and clinical teams, supervise staff or contractors, and drive QA/QC processes, data cleaning, reconciliation, and reporting to support submissions.

Qualifications

• Bachelor's degree in science or related field.
• 8+ years of progressive experience in pharma/biotech data management or related area.

Responsibilities

• Provide leadership and oversight of data management activities to ensure accuracy and regulatory compliance.
• Lead data management plans and cross-functional coordination with CROs and clinical operations.
• Supervise internal staff and external contractors; manage DM projects end to end.
• Develop and maintain SOPs/WIs and QA/QC processes for data collection and review.

Skills

Leadership

Vendor management

IWRS

Data management

EDC systems

Regulatory knowledge

Communication

Project management

Medidata RAVE

SAS

PL/SQL

Java

C++

Education

Bachelor's degree in science

Tools

Medidata RAVE

Oracle RDC

InForm

Veeva EDC

SAS

PL/SQL

Java

C++

Job description

PTC Therapeutics, Inc. is seeking an Associate Director, Clinical Data Management to provide leadership over data management activities for clinical databases, ensuring accuracy and regulatory compliance. Based in Warren, NJ with a flexible hybrid work model.

You will lead DM plans, coordinate with CROs and clinical teams, supervise staff or contractors, and drive QA/QC processes, data cleaning, reconciliation, and reporting to support submissions.