[Hiring] Senior Manager, Clinical Data Management @Deciphera Pharmaceuticals

Role Description

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.

Key Responsibilities:

• Clinical Data Management Leadership & Study Oversight
  • 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
• Vendor & Stakeholder Management
  • 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
• Leadership, Process & Continuous Improvement
  • Enhance CDM processes and strengthen cross functional collaboration
  • Support department initiatives as needed
• Inspection Readiness, Quality & Metrics
  • 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

Qualifications

• Bachelor’s or master’s degree with 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

Requirements

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

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.