Senior Manager, Clinical Data Management

Deciphera Pharmaceuticals • Waltham, MA

7d

About The Position

The Senior Manager, Clinical Data Management (CDM) leads data management activities for clinical studies or programs, ensuring high standards of data quality and integrity. The role may serve as lead CDM for multiple trials and is accountable for complex or pivotal studies. It works closely with internal stakeholders and external vendors to deliver high-quality clinical data on agreed timelines. The Senior Manager also supports inspection readiness and process improvement within the CDM function.

Requirements

• Bachelor’s or master’s degree.
• 8+ years of experience in Clinical Data Management.
• Effective communication, organizational, and project management skills.
• Knowledge of FDA/CFR and ICH/GCP.
• Familiarity with CDISC and CDASH standards.

Nice To Haves

• Experience leading complex or pivotal clinical trials.
• Vendor oversight experience.
• Inspection and audit support experience.

Responsibilities

• Serve as lead CDM for multiple clinical trials.
• Ensure data quality and data integrity for complex and/or pivotal clinical studies.
• Oversee all activities outlined in the Data Management Plan (DMP).
• Develop data acquisition strategies and ensure supporting systems are validated and meet intended study needs.
• Oversee outsourced CDM vendors and ensure their performance aligns with Deciphera standards.
• Participate in vendor selection and management.
• Review vendor invoices as applicable.
• Collaborate with the cross-functional team on data deliverables.
• Enhance CDM processes and strengthen cross-functional collaboration.
• Support department initiatives as needed.
• Lead CDM inspection activities and manage findings to resolution.
• Ensure CDM documentation is complete and filed in the TMF.
• Perform other duties and responsibilities as assigned.

Benefits

• Competitive salary and annual bonus.
• Comprehensive benefits package including medical, dental, and vision insurance, a 401(k) retirement plan with company match, and more.
• Generous parental leave and family planning benefits.
• Opportunities for personal and professional growth.
• Long-term incentive plan and other incentive compensation plans, if applicable. The job posting identifies these as components of its total rewards strategy.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior