Senior Manager, Clinical Data Management
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. The position works with internal stakeholders and external vendors to deliver high-quality clinical data on agreed timelines, and supports inspection readiness and process improvement within the CDM function. Responsibilities include overseeing study data management plans and data acquisition strategies, ensuring supporting systems are validated and suited to study needs, managing outsourced CDM vendors, collaborating with cross-functional teams, leading CDM inspection activities, and ensuring documentation is complete and filed in the TMF.
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 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.
- 401(k) retirement plan with company match.
- Generous parental leave and family planning benefits.
- Opportunities for personal and professional growth.
- Long-term incentive plan and other incentive compensation plans, if applicable.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
