Senior Manager, Clinical Data Management

Deciphera Pharmaceuticals, Inc.; Oregon; Ibrido; USD 164.000 - 200.000; Tempo pieno

Vantaggi offerti da questo lavoro

Annual bonus

Medical insurance

Dental insurance

Vision insurance

401(k) with match

Descrizione del lavoro

Deciphera Pharmaceuticals, Inc. seeks a Senior Manager, Clinical Data Management to lead data management activities across clinical studies, ensuring high data quality and integrity.

The role includes oversight of DMPs, collaboration with internal teams and external vendors, and driving process improvements to support inspection readiness. Ideal candidates will have 8+ years in Clinical Data Management, strong communication and project management skills, and familiarity with FDA/CFR, ICH/GCP,

Competenze

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

Mansioni

• Lead CDM activities for multiple clinical trials or programs.
• Ensure data quality and integrity for complex/pivotal studies.
• Oversee Data Management Plan (DMP) and vendor management.
• Collaborate with cross-functional teams to deliver data on time.
• Support inspection readiness and process improvements.

Conoscenze

Effective communication

Organizational skills

Project management

Formazione

Bachelor’s or Master’s degree in clinical data management or related field

Strumenti

CDISC/CDASH

Descrizione del lavoro

Company Description

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 we operate, 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:Job Description

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 OversightServe as lead CDM for multiple clinical trialsEnsure data quality and data integrity for complex and/or pivotal clinical studiesOversee all activities outlined in the Data Management Plan (DMP)Develop data acquisition strategies and ensure supporting systems are validated and meet intended study needsVendor & Stakeholder ManagementOversee outsourced CDM vendors and ensure performance align with Deciphera standardsParticipate in vendor selection and managementReview vendor invoices as applicableCollaborate with cross functional team on data deliverablesLeadership, Process & Continuous ImprovementEnhance CDM processes and strengthen cross functional collaborationSupport department initiatives as neededInspection Readiness, Quality & MetricsLead CDM inspection activities and manage findings to resolutionEnsure CDM documentation is complete and filed in the TMFOther duties and responsibilities as assigned

Qualifications

Bachelor’s or master’s degree with 8+ years of experience in Clinical Data ManagementEffective communication, organizational, and project management skillsKnowledge of FDA/CFR and ICH/GCPFamiliarity with CDISC and CDASH standardsPreferred Capabilities:Experience leading complex or pivotal clinical trialsVendor oversight experienceInspection and audit support experience

Additional Information

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)

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.

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.

Job Location: Remote