Senior Manager, Clinical Data Management
Deciphera Pharmaceuticals · Waltham, MA · 3 wk ago
HybridScience$145k–$200k/yrFull-time
Key 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
Qualifications
- 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
- Experience leading complex or pivotal clinical trials (preferred)
- Vendor oversight experience (preferred)
- Inspection and audit support experience (preferred)
Additional Information
Deciphera is committed to fair and equitable compensation practices. The base salary pay range for this role is $145,000 - $200,000. Actual compensation packages will depend on various factors, including, but not limited to depth of experience, education, skillset, overall performance and/or location.
Deciphera believes in providing a competitive compensation and benefits package to all employees. Our base salary is just one component of Deciphera’s competitive total rewards strategy that also includes annual performance bonus, a long-term incentive plan, full range of benefits and other incentive compensation plans (if applicable).
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