Senior Director, Clinical Data Strategy & Operations

PTC Therapeutics, Inc; New Jersey; Hybrid; USD 200,700 - 252,600; Full time

Job summary

PTC Therapeutics, Inc is seeking a Director of Clinical Data Management to provide strategic leadership and oversight of data management activities for clinical databases. The role ensures data quality, integrity, and inspection readiness while guiding the use of EDC systems and other data applications.

The incumbent leads vendor relationships and cross-functional collaboration across Clinical Operations, biostatistics, and QA to deliver high-quality data for regulatory submissions.

Qualifications

• Bachelor's degree in science or related field.
• Minimum 10 years of relevant experience in pharma/biotech data management.
• Leadership of data management teams and vendor management experience.

Responsibilities

• Lead data management activities and oversee data quality and integrity.
• Oversee CROs and manage data management projects from start to finish.
• Collaborate with Clinical Operations, biostatistics, and SAS programmers to design data collection tools.
• Ensure regulatory compliance and support audit/inspection readiness.

Skills

Leadership

Vendor management

IWRS

ePRO/eCOA

Regulatory submissions

Data management

SAS

EDC systems

Cross-functional collaboration

Project management

Education

Bachelor's degree in science or related field

Tools

Medidata

Oracle RDC

InForm

Veeva EDC

Spotfire

J-Review

Business Objects

SAS

PL/SQL

Job description

PTC Therapeutics, Inc is seeking a Director of Clinical Data Management to provide strategic leadership and oversight of data management activities for clinical databases. The role ensures data quality, integrity, and inspection readiness while guiding the use of EDC systems and other data applications.

The incumbent leads vendor relationships and cross-functional collaboration across Clinical Operations, biostatistics, and QA to deliver high-quality data for regulatory submissions.