For our client in Basel we are looking for Trial Monitoring Trial Operations Manager (TOM) for 6-month contract.
Duration : Asap to 06 / 07 / 2020
Under the direction of TOM Development Unit Head, the TOM is accountable for the oversight and coordination of the global monitoring operational aspects of assigned clinical trials, from start-up to close-out, in collaboration with GCT / ICT / CTTs, regions and CPOs, in compliance with Company processes, GCP, ICH and regulatory requirements.
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.
The TOM contributes to the implementation of the Trial Monitoring strategy in the assigned clinical trials.
Must haves :
Minimum requirements : College or university degree with significant life science experience
Desired : Advanced degree, preferably in life sciences
Fluent in both written and spoken English.
At least 5 years’ experience in clinical research, in planning / executing and / or monitoring 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, without direct reports, but can coordinate the activities of others
Project / trial management and / or CRA or CRA management, Clinical Study Managers experience preferred
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, standards, and clinical development process
Understand and apply medical and business knowledge to clinical trial execution
Skills & Knowledge :
Excellent negotiation and conflict resolution skills
Demonstrated ability to influence without direct authority
Strong interpersonal skills
Excellent organizational, interpersonal skills with extensive networking expected
Communicates effectively with senior leaders in a local / regional / global matrixed environment
Major Accountabilities :
Trial Monitoring strategy :
Partners and agrees with GPT / GCT / ICT / CTT on trials execution plans and timeline commitments in alignment with Trial Monitoring strategy and on behalf of the Trial Monitoring organization to achieve global and regional / local business.
Communicates planned milestones to Trial Monitoring stakeholders and update GCT / ICT / CTTs on operational activities at the Region / CPO level, during the course of the trials to meet GPT Objectives
Participates 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
Is a core member of the assigned TOM Development Unit Team
Actively participates in the development of reporting methodologies, and implements performance reporting for trial monitoring, ensures accurate and complete operational data within corporate systems (i.e ClinAdmin, DARWIN)
May be the delegate of TOM Development Unit Head for specific teams or activities
Allocation, initiation and conduct of trials :
Is responsible to have trials execution according to enrolment commitment and timelines delivered per established GDD 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 and CPOs.
Evaluates potential challenges / risks within the protocol and operational aspects of the study; assessing impacts, developing risk management plans and communicating / escalating, 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
Reviews, approves, and ensures updates to CCGs as appropriate during trial conduct. Performs User Acceptance Testing for EDC system.
Contributes to the development of the DHP and DRP
Leads / co-chairs with study lead meetings with local study teams, is a member of the global clinical trial team and represents Trial Monitoring, is the single point of contact for the conduct of assigned trials
Is the author of the monitoring plan and following updates (as needed), trains monitors on the monitoring plan and updates
Distributes regulatory documents such as Protocol, ICFs, IBs and all related Amendments to CPOs
Facilitates development of trial level operational training materials within CTT with relevant line functions
Drives trial startup by coordinating preparation of FPP by respective CTT LF members, acceptance by CPOs, and tracking progress of SSU milestones (RIS, SIVs, FPFVs) in alignment with CTT, regions, and CPOs
Is accountable for recruitment activities as per targets and reviews enrolment at the trial level, including responsibility for approval of changing recruitment commitment.
Is responsible for forecasting, setting up contingency planning to ensure recruitment targets are achieved in accordance with trial execution plan, including communication of timelines for major milestone deliverables from start to end of enrollment, in coordination with CTT, regions and CPOs (with Clinical Study Managers) (...)