Senior Manager, Clinical Data Management

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.