Job Description

The Role:

We are seeking a Manager to Lead Clinical Data Management (CDM) activities for clinical studies or a clinical program. This position will report to the Associate Director/Director of CDM and work on-site at our Waltham, MA office. Deciphera embraces a flexible workplace. You will work out of our Waltham, Massachusetts office. Deciphera expects a minimum number of in-office days. Specific days spent in the office should be determined in conjunction with your manager.

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 highly 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.
• review invoices
• 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
• Plan the data acquisition for the clinical studies in the program, ensuring the computerized data systems are adequate and fit for purpose and the testing aligns with the risk and criticality of the data and the validation needs of the computerized data system
• Ensure the activities described in the Data Management Plan (DMP) are executed in accordance with the DMP, including data acquisition, data transfer, data reconciliation and review, medical coding, data extract and rolling data freeze, data lock and database lock
• 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)
• 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; this may include development of specifications, validation documentation or perform validation

Qualifications

What You’ll Bring:

• Bachelor’s or master’s degree, plus 8+ 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)

Additional Information

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
• An annual lifestyle allowance
• 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
• [if applicable] Car allowance

Deciphera, a member of ONO, is a company headquartered in Waltham, Massachusetts. Our state-of-the-art research facility is located in Lawrence, Kansas and our European operations are run out of Switzerland.

EQUAL EMPLOYMENT OPPORTUNITY INFORMATION

Deciphera is committed to equal employment opportunity and values diversity. To ensure that we comply with reporting requirements and to learn more about how we can increase diversity in our candidate pool, we invite you to voluntarily provide demographic information in a 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. Our commitment to increasing diversity in our candidate pool does not affect our commitment to equal employment opportunity, including our ongoing commitment to make all hiring and other employment decisions solely on a nondiscriminatory basis.