Associate Director, Clinical Data Management

Job Description

Exciting time to be joining Deciphera as we continue to build an amazing Clinical Data Management Team. Come join our dedicated and forward-thinking DM group as we embrace innovative technologies and processes in this evolving industry. We are seeking an Associate Director of CDM to lead clinical data management activities across one or more clinical programs or therapeutic areas within the portfolio. This position will report to the Director or Sr. Director Head, of Clinical Data Management.

What You'll Do:

• Ensure the data quality and data integrity for highly complex or pivotal clinical studies
• May manage escalations and ensure that optimal relationships are developed with the outsourced CDM vendor
• May help select and manage CDM vendors and ensure their performance is consistent with Deciphera standards
• May review and approve 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 expert CDM guidance to study teams, vendors and management
• Resolve complex technical or procedural issues and manage the escalation of issues
• Communicate issues and ongoing study and program updates to management
• May oversee and develop team of CDM staff
• May identify and evaluate modern technology and propose to management
• May contribute to projects involving standard ways of collecting and harmonizing clinical trial data, such as standard eCRFs, standard validation checks and conventions
• Ensure CDM activities are executed in accordance with all relevant SOPs and study plans
• Ensure CDM documentation is filed according to SOPs and the study plans
• Support inspection activities and manage any findings to resolution
• Participate 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
• May propose and define Key Risk Indicators (KRIs) and Quality Threshold Limits (QTLs) related to clinical trial data and sites.
• 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
• Function as the CDM subject matter expert for process related questions from other Clinical Data Managers, cross functional colleagues and business improvement teams

Qualifications

What You’ll Bring:

• Bachelor’s or master’s degree, plus 12+ years of experience; or PhD or equivalent plus 8+ years of experience

• Knowledge of clinical trial design and analysis activities and basic knowledge of regulatory guidelines (FDA/CFR, ICH/GCP), CDISC standards and eCTD submission requirements
• Excellent communication and critical thinking skills
• Excellent organizational and project management skills

Additional Information

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.

Apply Now: Join us in our mission to improve the lives of people with cancer. Apply today to become a part of our dynamic team!

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.