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R&D Partners
http://www.r-dpartners.com
http://www.r-dpartners.com
Senior Trial Operations Manager
New Jersey All, NJ
Posted: 12/02/2019
2019-12-02
2020-01-11
Job Type: Clinical
Job Number: JN -122019-26058
Region: New Jersey All
Job Description
- 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