Company:
Deciphera Pharmaceuticals, Inc
Location: Waltham
Closing Date: 29/10/2024
Salary: £125 - £150 Per Annum
Hours: Full Time
Type: Permanent
Job Requirements / Description
Senior Manager, Clinical Data Management
- Full-time
- Work Type: Full time
- Job Location: On-Site Waltham
Deciphera, a member of ONO, is a biopharmaceutical company focused on discovering, developing and commercializing important new medicines to improve the lives of people with cancer.
We are seeking a Senior Manager to lead Clinical Data Management (CDM) activities for clinical studies or clinical program(s). This position will report to the Associate Director/Director of CDM and work on-site at our Waltham, MA office.
What You’ll Do:
- May simultaneously function as lead CDM for multiple clinical trials or oversee the data management across a program
- Accountable for the data quality and data integrity for complex or pivotal clinical studies
- Oversee the work of the outsourced CDM vendor for assigned projects
- May contribute to vendor selection and management to ensure performance is consistent with Deciphera standards.
- Forecast timelines and resources required to complete study-specific tasks on time and with high quality
- Work collaboratively with stakeholders in Medical Affairs, Regulatory, PV to determine dates of program data deliverables.
- Provide guidance on clinical data management to CDM staff, study teams, vendors, and management
- Manage the escalation of study related issues and communicate as appropriate with management
- Present ongoing study updates to management
- May supervise one or several CDM staff members
- Plan the data acquisition for the clinical studies in the program, ensuring the computerized data systems are adequate and fit for purpose
- Ensure the activities described in the Data Management Plan (DMP) are executed in accordance with the DMP
- Ensure that CDM documentation is filed into the Trial Master File (TMF) according to SOPs and the study plans; review CDM files for completeness and accuracy
- Lead inspection activities for CDM and manage any findings to resolution.
- Active participant in the development and revision of Standard Operating Procedures (SOPs)
- Define metrics to measure clinical trial database quality, site and vendor performance and implement those metrics in the clinical trials
- Analyze metrics across projects and programs; escalate or inform management and cross functional colleagues to trends.
- Facilitate resolution of operational problems, issues, obstacles and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholders.
- Assist with development of therapeutic area standards for Case Report Forms and Edit Checks
- Assist in the coordination of the acquisition and development of tools to support data management tasks internally and externally with DM vendors.
What You’ll Bring:
- Bachelor’s or master’s degree, plus 10+ years of experience
- Excellent communication and critical thinking skills
- Excellent organizational and project management skills
- Familiarity with clinical trial design and analysis activities and basic knowledge of regulatory guidelines (FDA/CFR, ICH/GCP)
- Familiarity with CDISC standards
Deciphera offers a comprehensive benefits package that includes but is not limited to the following:
- Non-accrual paid time off
- Summer vacation bonus
- Global, company-wide summer and winter shutdowns
- Monthly cell phone stipend
- Internal rewards and recognition program
- Medical, Dental, and Vision Insurance
- 401(k) retirement plan with company match
- Life and Supplemental life insurance for family
- Short and Long Term Disability insurance
- Health savings account with company contribution
- Flexible spending account for either health care and/or dependent care.
- Family planning benefit
- Generous parental leave
EQUAL EMPLOYMENT OPPORTUNITY INFORMATION
Deciphera is committed to equal employment opportunity and values diversity.
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Deciphera Pharmaceuticals, Inc