Senior Clinical Data Management Lead
4 days ago
About Deciphera Pharmaceuticals
">Deciphera Pharmaceuticals is a biopharmaceutical company dedicated to discovering, developing, and commercializing innovative medicines for cancer treatment. With a proprietary switch-control kinase inhibitor platform and deep expertise in kinase biology, we are advancing a diverse pipeline of drug candidates.
">About the Role
">We seek an Associate Director, Clinical Data Management, to lead clinical data management activities across one or more clinical programs or therapeutic areas within our portfolio. This position will report to the Director or Senior Director Head of Clinical Data Management.
">Key Responsibilities
">- ">
- Ensure high-quality data and data integrity for complex or pivotal clinical studies.">
- Manage escalations and develop optimal relationships with outsourced CDM vendors.">
- Select and manage CDM vendors, ensuring their performance meets Deciphera standards.">
- Review and approve invoices.">
- Forecast timelines and resources required to complete study-specific tasks on time and with high quality.">
- Collaborate with stakeholders in Medical Affairs, Regulatory, and PV to determine program data deliverables.">
- Provide expert CDM guidance to study teams, vendors, and management.">
- Resolve complex technical or procedural issues and manage issue escalations.">
- Communicate issues and ongoing study and program updates to management.">
- Oversight and development of a team of CDM staff.">
- Identify and evaluate modern technology and propose to management.">
- Contribute to projects involving standard ways of collecting and harmonizing clinical trial data.">
- Ensure CDM activities adhere to all relevant SOPs and study plans.">
- Maintain CDM documentation according to SOPs and study plans.">
- Support inspection activities and manage findings to resolution.">
- Participate in SOP development and revision.">
- Define metrics to measure clinical trial database quality, site, and vendor performance.">
- 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 operational problem resolution, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholders.">
- Assist in developing therapeutic area standards for Case Report Forms and Edit Checks.">
Qualifications
">- ">
- Bachelor's or Master's degree plus 12+ years of experience or PhD/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.">
Salary Information
">We offer a highly competitive compensation package, including a base salary of $**160,000**, comprehensive benefits, and additional perks.
">Location
">Our state-of-the-art research facility is located in Lawrence, Kansas, while our European operations are based in Switzerland.
">About Us
">We are committed to equal employment opportunity and value diversity. To ensure compliance with reporting requirements and 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 and has no effect on your opportunity for employment.
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