• Accountable for the oversight and coordination of the global Monitoring operational aspects of assigned clinical trials with particular focus on pivotal trials, from start-up to close-out
• Scope of activities range from trial start-up to close-out including strategic and operational planning, feasibility assessment, trial allocation, start-up activities coordination, patient recruitment, clinical data collection and delivery of timely, high quality submission data, sites close-out, audit organization and inspection preparation activities
• Contribute to the implementation of the Trial Monitoring strategy in the assigned clinical trials
• Communicates planned milestones to Trial Monitoring stakeholders and updates study teams on operational activities
• Participate in the development of innovative solutions in clinical trial planning and execution, including country, site and patient engagement to ensure the delivery of assigned studies on time
• Provides ongoing information and regular updates to the Trial Monitoring organization, including remediation actions
• Participates to the development of reporting methodologies, and implements performance reporting for trial monitoring, ensures accurate and complete of operational data within corporate systems
• Responsible to have trials execution according to enrolment commitment and timelines delivered per established key performance indicators
• Develops planning for prospective management of clinical trials including operational risks for each phase of the trial (Feasibility/allocation, Start-up, Data collection and cleaning) using available internal and external resources (patients' incidence, competitive landscape regional strategies, data, statistical plan)
• Drives conduct of medical and operational feasibilities and communicates aggregated feedback to clinical teams; supports protocol development based on the feasibility feedback collected, ensures feedback given during feasibility process is answered and provided to regions
• Evaluates potential challenges/risks within the protocol and operational aspects of the study
• Assesses impacts, develops risk management plans and communicates/escalates, as appropriate
• Leads trial allocation process to ensure adequate patient accessibility and alignment with regional and country strategies, including re-allocation or corrective action when needed

Skills:

• Bachelor s degree is required
• At least 8 years of clinical research experience including the planning, executing and monitoring of clinical trials
• Solid understanding of all aspects of clinical drug development with particular emphasis on clinical trial design, trial execution, project management and operations
• Demonstrated ability to collaborate across partner functions in a matrix environment
• Project/Trial Management and CRA/Monitoring experience is required
• Proven ability to manage operational challenges at global, regional or country level for large complex trials with minimal supervision
• Excellent project management capabilities with demonstrated ability to problem solve and mediate complex issues
• Thorough knowledge of the international aspects of drug development process, the international standards (GCP/ICH), health authorities (FDA/EMEA), local/National health authorities regulations, and clinical development process
• Excellent negotiation and conflict resolution skills
• Demonstrated ability to influence without direct authority
• Strong interpersonal skills
• Excellent organizational, interpersonal skills with extensive networking
• Communicates effectively with senior leaders in a local/regional/global matrixed environment