Manager, Clinical Operations - Monitoring Oversight (m/f/d)

at  Otsuka Pharma GmbH

The Manager, Clinical Operations works closely with the OPDC Monitoring Oversight Lead to manage monitoring oversight activities including managing Clinical Monitoring Consultants (CMC) contracted to perform monitoring oversight duties as well as escalating issues related to CRO monitoring quality. While focusing on quality and compliance, uses metrics and key performance indicators to drive monitoring oversight activities to achieve timelines and deliverables across the portfolio. Additionally, the Manager, Clinical Operations will support planning, resourcing, contracting, and budgeting of CMC resources to conduct monitoring oversight tasks. The Manager, Clinical Operations will also coordinate review and reporting of CRO related Key Performance Indicators (KPIs) to the Monitoring Oversight Lead.

• Manage Monitoring Oversight activities in EU, Africa and Near East regions, and other regions as assigned
• With the OPDC Monitoring Oversight Lead, plan conduct of Oversight Accompanied Visits (OAV) in the assigned region(s)
• Manage, onboard, train and evaluate CMC resources to perform monitoring oversight tasks
• Ensure adherence to training requirements for assigned CMCs (SOPs and study specific training)
• Report status and output of OAVs and other monitoring oversight activities to OPDC Oversight Lead
• Review OAV reports and manage timelines and deliverables
• Oversee FSP monitoring resources in assigned region(s) as applicable
• Support implementation and improvement of monitoring oversight related processes
• Ensure compliance with Otsuka policies and procedures and applicable Key Performance Indicators (KPIs)
• Provide oversight of required metrics across all monitoring oversight service providers and contribute to monthly reporting of monitoring oversight related KPIs to CM&O Management
• Conduct Assessment Visits of CMCs to assess quality and compliance with applicable policies and procedures per the monitoring oversight job aids
• Escalate significant issues related to oversight visits (e.g., site, study, CRA, etc.) in a timely manner to the Monitoring Oversight Lead, Clinical Operations management, and Study Management as applicable
• Ensure compliance with clinical systems use and updates
• Provide support for internal audit and regulatory inspection activities as applicable
• Review study specific monitoring plans and provide feedback prior to implementation
• Collaborate with CMC staffing vendors, as applicable
• Manage consultant CMC contracts, budgets, and expenses to meet forecasts and support the development of annual regional monitoring oversight budget
• Other monitoring oversight activities as assigned by OPDC Oversight Lead
• Experience managing field-based Clinical Research Associates
• Demonstrated ability to lead teams
• Proficient with on-site monitoring activities (Site Qualification Visit, Site Initiation Visit, Interim Monitoring Visit, and Close Out Visit)
• Demonstrated strengths with critical thinking and analytical skills, oral and written communication, time management, conflict management, problem solving, attention to detail, and interpersonal skills
• Ability to supervise, direct and lead team members as well as interact with other internal staff and external vendors
• Strong planning and organization skills with the ability to multi-task and plan activities are they relate to field monitoring operations
• Both working and theoretical knowledge of ICH GCP Guidelines, FDA CFR, PhRMA code, site management, and regulatory compliance
• Excellent written and verbal communication skills and strong interpersonal skills necessary to interface with team members, outside vendors and consultants
• Possess advanced computer skills (e.g., Microsoft applications, etc.)
• Financial management skills as applicable to oversee initiatives and system expenditures
• Ability to handle and prioritize multiple tasks
• Ability to work effectively in a team/matrix environment
• Ability to travel up to 30% including ground and air travel

• Manage Monitoring Oversight activities in EU, Africa and Near East regions, and other regions as assigned
• With the OPDC Monitoring Oversight Lead, plan conduct of Oversight Accompanied Visits (OAV) in the assigned region(s)
• Manage, onboard, train and evaluate CMC resources to perform monitoring oversight tasks
• Ensure adherence to training requirements for assigned CMCs (SOPs and study specific training)
• Report status and output of OAVs and other monitoring oversight activities to OPDC Oversight Lead
• Review OAV reports and manage timelines and deliverables
• Oversee FSP monitoring resources in assigned region(s) as applicable
• Support implementation and improvement of monitoring oversight related processes
• Ensure compliance with Otsuka policies and procedures and applicable Key Performance Indicators (KPIs)
• Provide oversight of required metrics across all monitoring oversight service providers and contribute to monthly reporting of monitoring oversight related KPIs to CM&O Management
• Conduct Assessment Visits of CMCs to assess quality and compliance with applicable policies and procedures per the monitoring oversight job aids
• Escalate significant issues related to oversight visits (e.g., site, study, CRA, etc.) in a timely manner to the Monitoring Oversight Lead, Clinical Operations management, and Study Management as applicable
• Ensure compliance with clinical systems use and updates
• Provide support for internal audit and regulatory inspection activities as applicable
• Review study specific monitoring plans and provide feedback prior to implementation
• Collaborate with CMC staffing vendors, as applicable
• Manage consultant CMC contracts, budgets, and expenses to meet forecasts and support the development of annual regional monitoring oversight budget
• Other monitoring oversight activities as assigned by OPDC Oversight Lead
• Experience managing field-based Clinical Research Associates
• Demonstrated ability to lead teams
• Proficient with on-site monitoring activities (Site Qualification Visit, Site Initiation Visit, Interim Monitoring Visit, and Close Out Visit)
• Demonstrated strengths with critical thinking and analytical skills, oral and written communication, time management, conflict management, problem solving, attention to detail, and interpersonal skills
• Ability to supervise, direct and lead team members as well as interact with other internal staff and external vendors
• Strong planning and organization skills with the ability to multi-task and plan activities are they relate to field monitoring operations
• Both working and theoretical knowledge of ICH GCP Guidelines, FDA CFR, PhRMA code, site management, and regulatory compliance
• Excellent written and verbal communication skills and strong interpersonal skills necessary to interface with team members, outside vendors and consultants
• Possess advanced computer skills (e.g., Microsoft applications, etc.)
• Financial management skills as applicable to oversee initiatives and system expenditures
• Ability to handle and prioritize multiple tasks
• Ability to work effectively in a team/matrix environment
• Ability to travel up to 30% including ground and air trave