Senior Manager, Clinical Data Management & Data Quality (Hybrid)

PTC Therapeutics, Inc; New Jersey; Hybrid; USD 130,000 - 163,000; Full time

Benefits offered by this job

Hybrid work model

Job summary

PTC Therapeutics, Inc. in New Jersey seeks a Senior Manager, Clinical Data Management to oversee data management activities, ensuring accuracy and consistency of clinical databases for analysis and reporting.

This role involves database development, EDC processes, and collaboration with CROs and internal teams to define sponsor processes, QA/QC documentation, and data management plans to support timely study deliverables.

Qualifications

• Bachelor's degree in science or related field with at least 7 years of progressive experience in pharma/biotech/CRO.
• Experience leading vendor management and working with IWRS, imaging, PRO and related data technologies.
• Knowledge of ICH, 21 CFR Part 11 and FDA guidelines; familiarity with CDISC/SDTM is preferred.

Responsibilities

• Oversee data management plans and CRO data management activities.
• Develop CRFs with Clinical Operations and biostatisticians for statistical analysis.
• Manage data cleaning, lock processes, and data processing for trials.
• Prepare and distribute study status reports and QA/QC documentation.
• Lead outsourcing strategy and manage relationships with external partners.

Skills

IWRS

Imaging

PRO

Database technologies

ICH guidelines

FDA guidelines

Medidata RAVE

CDISC SDTM

Regulatory requirements

SQL databases

Spotfire

J-Review

MS Office

Education

Bachelor's degree in science

Tools

Medidata RAVE

Oracle InForm

MS SQL Server

MS Access

Spotfire

J-Review

Job description

PTC Therapeutics, Inc. in New Jersey seeks a Senior Manager, Clinical Data Management to oversee data management activities, ensuring accuracy and consistency of clinical databases for analysis and reporting.

This role involves database development, EDC processes, and collaboration with CROs and internal teams to define sponsor processes, QA/QC documentation, and data management plans to support timely study deliverables.