Director Oncology Clinical Risk Management

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J&J Innovative Medicine is recruiting for a Director Oncology Clinical Risk Management reporting to the Sr.

Director Oncology CRM within the Clinical Risk Management (CRM) department.

Position Summary

The Director Oncology Clinical Risk Management oversees the overall risk management of the Late Development Hematology Disease Area Stronghold.

They work with the CRM Representatives to ensure the coordination of the identification, assessment, and mitigation of quality risks that could have an impact on trial data integrity, patient rights, safety, or well-being.

Throughout the duration of the program, the Director oversees the execution of data-driven, risk-based trial and program oversight activities that deliver quality in the execution of clinical trial programs, compliance with regulatory requirements and internal procedures, and that there is a continued state of inspection readiness.

Major Duties & Responsibilities

People Leader Responsibilities

• Establishes goals and objectives for CRM Representatives

• Performs mid-year and end-of-year review for CRM Representatives

• Assists in outlining and evaluating career development goals with CRM Representatives

• Works with team members to establish workstreams to update processes for efficiencies and maintaining inspection readiness

• Coordinates upskilling knowledge workshop series for CRM Representative team development

Risk Management

Independently, the Director Oncology Clinical Risk Management:

• Ensures CRM representatives are invited to actively participate in pre-study activities, contributing to the identification and assessment of key risks in the clinical protocol/set-up and advising clinical/cross functional trial team members on effective mitigation strategies.

• Ensures a consistent quality risk assessment process across the program

• Provides and leads strategic guidance to CRM representatives on quality risk assessments, risk entries, and mitigation strategies.

If assigned, approves IQP (Integrated Quality Plans) risk monitoring information in quality risk repository to facilitate regular progress reviews

• Independently drives quality risk monitoring reviews and coaches others on risk monitoring and mitigation reviews

• Ensures a strategic communication framework with business partners and quality management governance to keep them informed on key quality risks and mitigations.

• Communicates and facilitates risk updates ...