Contractor, Clinical Data Management Lead

PTC Therapeutics, Inc; New Jersey; On-site; USD 83,000 - 110,000; Full time

Job summary

PTC Therapeutics, Inc. is seeking a Contractor, Clinical Data Management to oversee data management activities across clinical databases, ensuring accuracy and regulatory compliance.

The role involves database development using EDC systems and collaboration with CROs and internal teams to align on data collection and QA/QC documentation. The successful candidate will manage data cleaning and lock processes, develop DM plans and CRFs, and coordinate with external vendors to ensure timely delivery

Qualifications

• Bachelor's degree in science with 7+ years of relevant progressively responsible experience in a pharmaceutical, biotech, CRO, or regulatory agency.
• Experience leading vendor management and external data partners in clinical trials.
• Strong knowledge of industry standards such as ICH guidelines, 21 CFR Part 11, and FDA guidelines.
• Medidata RAVE and related data management systems experience.
• Ability to develop data management plans and create CRFs for data capture and analysis.

Responsibilities

• Oversee data management activities to ensure data accuracy and consistency of clinical databases.
• Collaborate with CROs, Clinical Operations, biostatisticians, and SAS programmers to develop CRFs for analysis.
• Develop data management plans and oversee database development, cleaning, and lock activities.
• Coordinate with external vendors for data collection, transmittal, and transfer of study data.
• Prepare periodic reports on study status, CRF completion, and query aging.
• Ensure compliance with SOPs and regulatory requirements across projects.

Skills

IWRS

Medidata RAVE

CDISC/SDTM

Regulatory compliance

Data management plans

Vendor management

SAS programming

Education

Bachelor's degree in science

Tools

Oracle InForm

MS SQL Server

MS Access

Spotfire

J-Review

Job description

PTC Therapeutics, Inc. is seeking a Contractor, Clinical Data Management to oversee data management activities across clinical databases, ensuring accuracy and regulatory compliance.

The role involves database development using EDC systems and collaboration with CROs and internal teams to align on data collection and QA/QC documentation. The successful candidate will manage data cleaning and lock processes, develop DM plans and CRFs, and coordinate with external vendors to ensure timely delivery