Senior Manager, Regional Country Clinical Operations Lead, Japan

Position Summary:

ultrafocused – Work together to fearlessly uncover new possibilities

The R/CCOL is accountable for study management, study and site oversight as well as site relationship management for a region/country in the Asia Pacific (APAC) region with accountability for all allocated operational study deliverables across programs. The R/CCOL is a key contributor to the strategy of operational activities for a region/country in APAC related to study milestone planning, country and site selection, recruitment planning, investigator relationship management, and site monitoring oversight. The R/CCOL will proactively support several Study Management Teams (SMTs)/Programs in collaboration with Ultragenyx´s key stakeholders including Global Medical Affairs (Patient Find, Patient Diagnosis Liaisons, MSLs, Medical Information), Patient Advocacy, Clinical Operations Program Leads, Lead Study Managers and Global Investigator Site Monitoring and Management. 

The R/CCOL will optimize performance with a focus on high quality, time and cost effectiveness, following quality standards, SOPs and guidelines aligned with local regulations and ICH/GCP guidelines by being a champion of the Ultragenyx patient centric culture. Outstanding interactions between Ultragenyx as a Sponsor with rare disease investigator sites is key to optimizing strong relationships and successfully executing our clinical trials. The R/CCOL will work with the Exec Director, Global Clinical Operations to drive operational excellence for Global Clinical Operations.

Work Model:

Remote: Officially documented as working full-time from home, with travel to Ultragenyx's offices or other locations on occasion as needed.

Responsibilities:

• Effectively oversee the conduct of one or more trials, in one or more countries or region
• Drive country/region study deliverables, project timelines and milestones, as well as quality and compliance of the study in alignment with the global plan
• Facilitate strategic and tactical exchange of program, study, site level information and communication between UGX APAC community, including country affiliates, and Global Study Teams
• Act as a Subject Matter Expert for policies and country/regional regulations and for Sponsor Inspections by Regulatory Agencies or during audits
• Build and maintain effective relationships with investigator sites and internal/external stakeholder groups
• Coordinate and execute planning, startup, recruitment, maintenance and close-out activities at the study level across the assigned region/country
• Act as a point of contact and demonstrate leadership in the resolution of high/critical regional/country study or site issues
• Collaborate with CRO partners to proactively find solutions to meet any challenges to the study deliverables and project timeline milestones
• Provide strategic regional/country input into and review of key study specific study documents and training materials
• Identify potential study sites in collaboration with the study team, local Medical Affairs, and CRO
• Conduct feasibility assessment and make recommendations for site selection
• Support site initiation and close-out visits at selected clinical sites
• Manage implementation of Monitoring Oversight Plan and conduct selected Monitoring Oversight Visits with CRAs
• Review site visit reports for quality and completeness
• Support the Study Management Team in Sponsor and protocol level training in the country/region
• Support maintenance of Trial Master File to ensure study is always inspection ready
• Review quality metrics and provide solutions for continuous improvement
• Maintain a working knowledge of rare/ultrarare disease and protocols
• Support risk and issue management at country/region level
• Interact with other R/CCOLs to standardize study conduct and clinical monitoring processes across studies, and drive operational excellence
• Participate in initiatives and/or special projects, as assigned
• Participates in the development, review and implementation of Standard Operating Procedures, Work Instructions, Guidance Documents
• May mentor Clinical Operations staff (e.g., Study Engagement Leads)
• May serve as a people leader of one or more direct reports within a matrix environment, including, performance management, oversight and development plan guidance

Requirements:

• Bachelor’s degree or equivalent is required (scientific or healthcare discipline preferred)
• 12 plus years of extensive site management and monitoring experience across various disease areas and previous experience managing day-to-day operations of clinical trials
• Holding CRA certificate is highly considerable
• Solid knowledge of clinical development processes with strong emphasis on monitoring
• Excellent ability to manage and collaborate on complex protocols within a matrix environment 
• Expert knowledge of both ICH and Japan Good Clinical Practice guidelines
• Excellent planning and organizational skills
• Able to handle multiple tasks and deadlines 
• Must be self-motivating and able to work on problems of moderate scope and complexity where analysis of situations or data requires a review of a variety of factors
• Highly effective verbal and written communication skills
• Flexible and solution focused
• Strong customer focus
• Must have the ability to build and maintain positive relationships with clinical sites, peers and management
• Experience with partnering and managing CRO relationships
• Experience using computer applications including spreadsheets, MS Project, email, word-processing software and web-based systems
• Japanese native speaker and excellent written and verbal skills in English and Japanese
• 25% travel, dependent on need

Desired:

• Rare disease experience
• Additional language skills #LI-CK1  #LI-Remote