Trial Monitoring - Trial Operations Manager
A job vacancy for a Trial Monitoring - Trial Operations Manager has arisen at a leading global pharmaceutical company specialising in development of biological therapies. This company is one of the top 10 global pharmaceutical companies that operates in 140 countries worldwide and has market leading products in multiple therapy areas.
Trial Monitoring strategy:
- Partnering 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.
- Communicating 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.
- Participating 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.
- Providing ongoing information and regular updates to the Trial Monitoring organization, including remediation actions.
- 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).
Allocation, initiation and conduct of trials:
- Responsible to have trials execution according to enrolment commitment and timelines delivered per established GDD key performance indicators.
- Developing 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 communicate aggregated feedback to clinical teams.
- Supporting protocol development based on the feasibility feedback collected, ensures feedback given during feasibility process is answered and provided to regions and CPOs. Evaluating potential challenges/risks within the protocol and operational aspects of the study; assessing impacts, developing risk management plans and communicating/escalating, as appropriate.
- Leading trial allocation process to ensure adequate patient accessibility and alignment with Regional and Country strategies, including re-allocation or corrective action when needed.
- Reviewing, approving, and ensuring updates to CCGs as appropriate during trial conduct. Performs User Acceptance Testing for EDC system. Contributes to the development of the DHP and DRP.
- Leading/co-chairing 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.
- Author of the monitoring plan and following updates (as needed), trains monitors on the monitoring plan and updates.
- Distributing regulatory documents such as Protocol, ICFs, IBs and all related Amendments to CPOs.
- Facilitating development of trial level operational training materials within CTT with relevant line functions.
- Driving 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
- Accountable for recruitment activities as per targets and reviews enrolment at the trial level, including responsibility for approval of changing recruitment commitment.
Delivery of quality data and compliance to quality standards:
- Evaluating 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.
- Working 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.
- Supporting inspection readiness and submission preparation for monitoring related activities.
Skills and Requirements:
- Minimum requirements: College or university degree with significant life science experience.
- Desired: 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.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Anna Bigiotti at 0203 854 2470 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
A leading biopharmaceutical company is seeking to recruit an Early Development Physician (up to VP) to their office in Shanghai.
A unique Biotech based in Central London are looking for a Senior Manager, Clinical Operations/Associate Director to join their rapidly growing team.