Senior CDM Lead — Remote

Deciphera Pharmaceuticals, Inc.; Waltham (MA); Remote; USD 164,000 - 200,000; Full time

Benefits offered by this job

Annual bonus

Medical/dental/vision benefits

401(k) match

Parental leave

Job summary

Deciphera, a member of Ono Pharmaceutical Co., Ltd., is seeking a Senior Manager, Clinical Data Management to lead data management activities for clinical studies, ensuring high standards of data quality and integrity. This role may serve as lead CDM for multiple trials and will collaborate with internal stakeholders and external vendors to deliver data on agreed timelines.

The ideal candidate has 8+ years in CDM, strong knowledge of FDA/CFR and ICH/GCP, and familiarity with CDISC and CDASH

Qualifications

• Must have 8+ years of experience in Clinical Data Management.
• Familiarity with FDA/CFR and ICH/GCP.
• Experience leading complex or pivotal clinical trials.
• Inspection readiness and audit support experience.

Responsibilities

• Lead data management activities for clinical studies or programs.
• Ensure data quality and integrity for complex or pivotal studies.
• Oversee Data Management Plan (DMP) and validation of supporting systems.
• Oversee outsourced CDM vendors and vendor management.
• Collaborate with cross-functional teams on data deliverables.
• Lead CDM inspection activities and manage findings to resolution.

Skills

Effective communication

Organizational skills

Project management

Education

Bachelor’s or Master’s degree in Clinical Data Management

Tools

CDISC standards

CDASH standards

Job description

Deciphera, a member of Ono Pharmaceutical Co., Ltd., is seeking a Senior Manager, Clinical Data Management to lead data management activities for clinical studies, ensuring high standards of data quality and integrity. This role may serve as lead CDM for multiple trials and will collaborate with internal stakeholders and external vendors to deliver data on agreed timelines.

The ideal candidate has 8+ years in CDM, strong knowledge of FDA/CFR and ICH/GCP, and familiarity with CDISC and CDASH