Senior Manager, Clinical Data Management

Deciphera Pharmaceuticals; Waltham (MA); Remote; USD 164.000 - 200.000; Vollzeit

Benefits dieser Stelle

Annual bonus

Medical/dental/vision benefits

401(k) match

Parental leave

Zusammenfassung

Deciphera, a member of Ono Pharmaceutical Co., Ltd., is seeking a Senior Manager, Clinical Data Management to lead data management activities for clinical studies, ensuring high standards of data quality and integrity. This role may serve as lead CDM for multiple trials and will collaborate with internal stakeholders and external vendors to deliver data on agreed timelines.

The ideal candidate has 8+ years in CDM, strong knowledge of FDA/CFR and ICH/GCP, and familiarity with CDISC and CDASH

Qualifikationen

• Must have 8+ years of experience in Clinical Data Management.
• Familiarity with FDA/CFR and ICH/GCP.
• Experience leading complex or pivotal clinical trials.
• Inspection readiness and audit support experience.

Aufgaben

• Lead data management activities for clinical studies or programs.
• Ensure data quality and integrity for complex or pivotal studies.
• Oversee Data Management Plan (DMP) and validation of supporting systems.
• Oversee outsourced CDM vendors and vendor management.
• Collaborate with cross-functional teams on data deliverables.
• Lead CDM inspection activities and manage findings to resolution.

Kenntnisse

Effective communication

Organizational skills

Project management

Ausbildung

Bachelor’s or Master’s degree in Clinical Data Management

Tools

CDISC standards

CDASH standards

Jobbeschreibung

Senior Manager, Clinical Data Management

• Full-time
• Job Location: Remote

Deciphera, a member of Ono Pharmaceutical Co., Ltd., is a biopharmaceutical company focused on discovering, developing, and commercializing important new medicines and providing hope to people living with cancer, neurologic and autoimmune disease. The spirit of collaboration that has brought medications to life continues to guide how weoperate, grow, and discover new breakthroughs. We cultivate an inclusive culture that values curiosity, creativity, and shared accountability—empowering individuals to challenge the unknown together.Learn more about Deciphera, a member of Ono Pharmaceutical Co., Ltd., by visiting our website: https://deciphera.com

The Senior Manager, Clinical Data Management (CDM) leads data management activities for clinical studies or clinical programs, ensuring high standards of data quality and integrity. This role may serve as lead CDM for multiple trials, with accountability for complex or pivotal studies. The position works closely with internal stakeholders and external vendors to deliver high-quality clinical data on agreed timelines. The Senior Manager also supports inspection readiness and process improvement within the CDM function.

Key Responsibilities:
Clinical Data Management Leadership & Study Oversight

• Serve as lead CDM for multiple clinical trials
• Ensure data quality and data integrity for complex and/or pivotal clinical studies
• Oversee all activities outlined in the Data Management Plan (DMP)
• Develop data acquisition strategies and ensure supporting systems are validated and meet intended study needs
• Oversee outsourced CDM vendors and ensure performance aligns with Deciphera standards
• Participate in vendor selection and management
• Collaborate with cross functional team on data deliverables

Leadership, Process & Continuous Improvement

• Enhance CDM processes and strengthen cross functional collaboration
• Support department initiatives as needed

Inspection Readiness, Quality & Metrics

• Lead CDM inspection activities and manage findings to resolution
• Ensure CDM documentation is complete and filed in the TMF

Other duties and responsibilities as assigned

• Bachelor’s or master’s degree with 8+ years of experience in Clinical Data Management
• Effective communication, organizational, and project management skills
• Knowledge of FDA/CFR and ICH/GCP
• Familiarity with CDISC and CDASH standards

Preferred Capabilities:

• Experience leading complex or pivotal clinical trials
• Inspection and audit support experience

Deciphera is committed to fair and equitable compensation practices. The base salary pay range for this role is $164,000 - $200,000. Actual compensation packages will depend on various factors, including, but not limited to depth of experience, education, skillset, overall performance and/or location.

Deciphera believes in providing a competitive compensation and benefits package to all employees. Our base salary is just one component of Deciphera’s competitive total rewards strategy that also includes annual performance bonus, a long-term incentive plan, full range of benefits and other incentive compensation plans (if applicable)

• 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.

EQUAL EMPLOYMENT OPPORTUNITY INFORMATION

Deciphera is committed to equal employment opportunity and values diversity. To ensure that we comply with reporting requirements, we invite you complete the 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. We are committed to make all hiring decisions and other employment decisions on a non-discriminatory basis.

By clicking the link above or any third-party link within this posting, you are leaving this site and going to a third-party website where the third-party website's terms and privacy policy apply