Senior Manager, Clinical Data Management

Deciphera Pharmaceuticals • Waltham, MA

1d • $145,000 - $200,000 • Onsite

About The Position

The Senior Manager, Clinical Data Management (CDM) leads data management activities for clinical studies or clinical programs, ensuring high standards of data quality and integrity. This role may serve as lead CDM for multiple trials, with accountability for complex or pivotal studies. The position 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 with 8+ years of experience in Clinical Data Management
• Strong communication, organizational, and project management skills
• Knowledge of FDA/CFR and ICH/GCP
• Familiarity with CDISC 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)
• Plan data acquisition strategies and ensure data systems are fit for purpose and validated
• Oversee outsourced CDM vendors and ensure performance aligns with Deciphera standards
• Participate in vendor selection and management
• Review vendor invoices as applicable
• Collaborate with cross functional team on data deliverables
• Improve CDM processes and cross functional collaboration
• Participate in SOP development
• Lead CDM inspection activities and manage findings to resolution
• Ensure CDM documentation is complete and filed in the TMF
• Other duties and responsibilities as assigned

Benefits

• Competitive salary and annual bonus.
• Comprehensive benefits package including medical, dental, vision insurance, 401(k) retirement plan with company match, and more.
• Generous parental leave and family planning benefits.
• Outstanding culture and opportunities for personal and professional growth.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 101-250 employees