Trial Monitoring - Trial Operations Manager
The Trial Operations Manager will be accountable for the oversight and coordination of the global monitoring operational aspects of assigned clinical trials, from 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 and inspection preparation activities.
- Partners and agrees 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 updates on operational activities.
- 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 Trial Operations Manager (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.
- 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 global 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 and statistical plan).
- Drives conduct of medical and operational feasibilities and communicates aggregated feedback to clinical team.
- 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 Case Report Form Compliance Guidelines as appropriate during trial conduct.
- 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.
- Facilitates development of trial level operational training materials within Clinical Trial Team (CTT) with relevant line functions.
- 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.
- Coordinates clinical data collection as per plan, including contingency planning and communication of timelines for major database lock milestone deliverables.
- Ensures timely site close-out activities, in coordination with Clinical Trial Team and local teams.
- Delivery of quality data and compliance to quality standards.
- Evaluates potential challenges/risks within the protocol and operational aspects of the study in line with the prevailing legislation, GCP, Ethical Committee, and SOP requirements; assessing impacts, developing risk management plans and communicating/escalating to appropriate stakeholder.
- Works as needed with local teams (Clinical Study Managers, Country Heads) Monitoring Excellence group to address clinical data trends that may indicate issues with quality in trial execution.
- Supports inspection readiness and submission preparation for monitoring related activities.
- Participates and/or leads multidisciplinary taskforces to support continuous improvement and other management initiatives.
Qualifications and Experience:
- Advanced degree, preferably in life sciences.
- 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 authority’s regulations, and clinical development process.
- Understand and apply medical and business knowledge to clinical trial execution.
- Excellent negotiation and conflict resolution skills.
- Demonstrated ability to influence without direct authority.
- Excellent organizational, interpersonal skills with extensive networking expected.
- Communicates effectively with senior leaders in a local/regional/global matrixed environment.
- Fluent English (oral and written).
- Relevant working/residency permit or Swiss/EU-Citizenship required.