Senior Manager, Clinical Data Management
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Job Location:
Waltham, MA - USA
Monthly Salary:
Not Disclosed
Posted on:
5 hours ago
Vacancies:
1 Vacancy
Job Summary
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 75%
- 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
Vendor & Stakeholder Management 10%
- 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 10%
- Improve CDM processes and cross functional collaboration
- Participate in SOP development
Inspection Readiness Quality & Metrics 5%
- 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 :
Required Qualifications
- Bachelors or Masters 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
Preferred Capabilities
- Experience leading complex or pivotal clinical trials
- Vendor oversight experience
- Inspection and audit support experience
Additional Information :
Deciphera is committed to fair and equitable compensation practices. The base salary pay range for this role is $145000 - $200000. 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 Decipheras 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.
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EQUAL EMPLOYMENT OPPORTUNITY INFORMATION
Deciphera is committed to equal employment opportunity and values diversity. To ensure that we comply with reporting requirements we invite you complete the confidential survey at the end of this application. Providing this information is optional. It will not be accessible or used in the hiring process and has no effect on your opportunity for employment. This information will also be treated confidentially. We are committed to make all hiring decisions and other employment decisions on a non-discriminatory basis.
EQUAL EMPLOYMENT OPPORTUNITY INFORMATION
Deciphera is committed to equal employment opportunity and values diversity. To ensure that we comply with reporting requirements we invite you complete the confidential survey at the end of this application. Providing this information is optional. It will not be accessible or used in the hiring process and has no effect on your opportunity for employment. This information will also be treated confidentially. We are committed to make all hiring decisions and other employment decisions on a non-discriminatory basis.
Remote Work :
No
Employment Type :
Full-time
