Job Summary

The GOMA Governance Review Committee Office Manager leads evidence generation governance, operational oversight, and compliance of the global oncology review process for company-funded clinical studies, expanded access programs (EAP), and other related functions. This role ensures alignment with Daiichi Sankyo's strategic evidence generation objectives and regulatory standards by directing review committee operations, managing data integrity, and collaborating with Global Oncology Medical Affairs and cross-functional stakeholders to drive effective decision-making and governance.

Responsibilities

Governance Oversight:

• Lead and continuously improve the maintenance and implementation of governance frameworks to ensure robust oversight of the global oncology review process for company-funded clinical studies, expanded access programs, and other related functions.
• Drive compliance with Global Standard Operating Procedures (GSOPs) for regional and global reviews, by managing and tracking key milestones in alignment with contractual obligations.
• Oversee and optimize clinical systems for managing reviews and approvals of clinical study development and oversight activities, ensuring accuracy and regulatory compliance

Operational Leadership:

• Drive adherence to timelines, program objectives, and monitor plans associated with review committee processes.
• Lead the development, tracking, and analysis of key performance indicators (KPIs) related to the review process, including monitoring key milestones and showcasing trends in timelines to inform continuous improvement.
• Manage the execution of documentation of all activities, ensuring adherence to Good Documentation Practice (GDP), established timelines, quality standards and regulatory requirements.
• Maintain rigorous accuracy and real-time integrity of all data management activities, databases, and tracking systems critical to committee operations.
• Lead tracking and analysis of committee decisions, milestones, and documentation to drive operational efficiency and ensure compliance.

Collaboration and Stakeholder Engagement:

• Work closely with Functional and Regional Teams and key stakeholders to drive alignment on review committee activities and expectations.
• Serve as a liaison and provide regular updates and reporting on study and review activities to the Global Medical Affairs Team and other relevant functions.
• Establish strong partnerships with study and medical access program operational managers across regions and functions to support operational excellence in all related activities.

Process Improvement and Compliance:

• Lead initiatives to for the continuous improvement of process standards and tools that elevate review committee operations and governance to the highest level.
• Monitor compliance and enforce the highest quality standards across all review committee activities.
• Drive the creation and execution of Corrective and Preventative Action (CAPA) plans to resolve non-compliance issues and enhance committee operational integrity as assigned.

Systems and Data Management:

• Drive effective lifecycle milestone management for reviews by utilizing internal project management system tools to their full potential.
• Maintain strict and comprehensive oversight to uphold data accuracy and integrity across project management and tracking systems.
• Drive comprehensive training and hands-on support for team members to ensure proficient use of project management and data systems.

Quality Assurance and Regulatory Management:

• Work collaboratively with Governance, Quality Assurance and Regulatory teams to sustain and advance quality excellence across all committee activities.
• Drive preparation and execution quality events, audits and inspection activities as assigned to uphold high standards and effectively address findings effectively.
• Contribute to the effective implementation of corrective actions arising from audits or regulatory inspections related to review committee operations.

Qualifications

Education Qualifications
Bachelor's Degree required

Experience Qualifications
4 or more years minimum of 4 years of progressive experience in clinical development operations, review committee management, or related governance functions demonstrating increasing responsibility in leadership required

• Demonstrated expertise in clinical study development and oversight of review activities and governance processes within the pharmaceutical industry, preferably with a focus in oncology is advantageous required
• In-depth knowledge of Good Clinical Practice (GCP), International Council for Harmonisation (ICH) guidelines required 
• Comprehensive understanding of Medical Affairs functions, with direct experience working in or closely supporting Medical Affairs teams preferred 
• Proven capability to independently manage operational and compliance activities in alignment with pharmaceutical industry standards, regulatory expectations, and internal policies required
• Strong analytical and critical thinking skills with a track record of identifying compliance deviations, assessing risks, and driving process improvements required 
• Ability to interpret complex Standard Operating Procedures (SOPs), regulatory requirements, and guidelines, and translate them into actionable recommendations that influence business outcomes required 
  Experience in leading cross-functional collaboration, communicating effectively with senior stakeholders, and driving accountability to ensure compliance and operational excellence. required 
  
  Travel Requirements
  Ability to travel up to 5% of the time.