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Sr. Manager/Manager, Regional Trial Oversight

Elements for Sr Manager Regional Trial Oversight

Sr. Manager must have at least 8 years of work experience in investigational product development and ICH-GCP/J-GCP, including experience with oversight of study quality.

Sr. Manager must have the ability to lead and execute the activities and areas of responsibility as a Regional TO.

Overview of Sr. Manager Regional Trial Oversight

The Senior Manager, Regional Trial Oversight, is responsible for conducting and coordinating trial management oversight activities in collaboration with the trial teams as well as internal and external stakeholders to support the quality and integrity of the data across Genmab clinical trials. Furthermore, the senior manager is responsible for leading trial oversight processes and ensure alignment and coordination with relevant stakeholders. Regional Trial Oversight conducts the oversight activities for Japan, and other APAC countries if applicable.

Key Responsibilities/tasks of Sr. Manager Regional Trial Oversight
Trial oversight processes:

•Prepare, conduct, and follow up on Sponsor Oversight Visits

•Lead development of oversight processes and tools to maintain oversight

•Support cross functional process development to support oversight activities and support PEG process improvements

•Retrospective review of monitoring visit report and follow up letters and communication to trial teams

•Review CRO and site training compliance

•Facilitate and lead the update of POMs related to monitoring and oversight

•Lead proactive risk identification, assessment, and management

•Participate and lead to cross-functional working groups/projects/task forces related to Oversight activities e.g Dashboard development, ODC implementation of oversight tools

•Approval of dedicated CRA staff for CROs with a dedicated CRA allocation model

•Trending of non-compliance and PDs across sites/trials/vendors and bring to POC

Drug Development in Japan
• Support other Japan Development Operations functions’ activities (e.g. Clinical Trial Manager, R&D Process & Training Management) if applicable.
• Participate in preparation for and response to PMDA Inspection as a representative of JDO if required
• Proactively join a cross functional activity including a process development/improvement
• Participate in external initiatives/task force teams such as EFPIA and JPMA and bring experience and knowledge to the relevant stakeholders, if applicable

The Employee shall also render such other related services and duties as may be assigned from time to time by supervisor.

Competencies of Sr. Manager Regional Trial Oversight
• Significant understanding of trial execution (knowledge of the processes, procedures, and principles involved in conduction clinical trials)

• Significant experience in clinical drug development & ICH-GCP/J-GCP including the oversight of study quality (at least 8 years)
• Experience in leading & managing global teams is preferable
• Experience in PMDA inspection
• Ability to foster a “One Team” spirit, inclusive mindset
• Excellent written and oral English communication skills (business level)
• Demonstrated ability to lead & collaborate with cross-functional teams to drive operational excellence
• Ability to anticipate risks and issues with proactivity to offer solutions & to timely escalate issues when needed
• Ability to align with Corporate, Dev Ops and Clinical Oversight goals
• Outsourcing and vendor management experience
• Confidence to challenging status-quo thinking and behavior; can work with agility and an innovative mindset
• Experience in mentoring CTMs and CRAs

• Valid permanent residency in Japan

• Native level Japanese in verbal, reading, & writing

#LI-DNP

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