*job overview*:
*summary of responsibilities*:
- performs the central monitoring activities for multiple studies and ensures accurate tracking and status reporting of studies in their remit.
- manage portfolio of studies for a customer and act as a customer point of contact.
- collaborates in the development of central monitoring proposal text and review of costing, contributes to proposal strategy and development.
- collaborates in the development of sponsor presentations/bid defense support.
- ensures that tracking and status reporting are performed in a timely and accurate manner.
- applies data to recommend any required changes.
- supports pmo in preparation of initial risk management register and may prepare, distribute, and follow up study risk impact reports and coordinate site risk weighting.
- ensures critical data and process definition are implemented in edc design by data expert.
- conducts site risk assessment across multiple studies, works with study start up team members, reviews site outreach, pre-study visit reports and site risk assessment. Prepares site risk stratifications and proposes baseline site risk levels and initial site monitoring intervention levels.
- develops and establishes requirements including prescriptive risk factor mitigation strategies, sdv strategy, study-specific risk factor definition, variable risk factor trigger levels.
- develop the central monitoring and other applicable plans and any subsequent changes.
- manages configuration of tools, risk factors trigger levels, programming of study specific risk factors and central monitoring parameters and performs user acceptance testing of applicable tools.
- performs ongoing dashboard reviews, prepares, and recommends mitigation actions and reviews recommended monitoring levels with project team and ensures that identified issues are followed to resolution.
- agrees potential changes to monitoring intervention level with project team in line with the applicable plans and escalates appropriately.
- performs study analytics reviews as per the applicable plans and communicates the findings appropriately.
- reviews and approves changes to monitoring levels, ensuring compliance with applicable plans and sponsor needs are met.
- oversees project quality and risk reports to ensure client satisfaction and compliance.
- coaches assigned project teams internally and externally to increase the central monitoring competence.
- contributes to the development and maintenance of processes, including sop writing, process mapping and process improvements using six sigma and lean methodologies.
- evaluates and collates process improvement suggestions and submits to leadership.
- evaluates and submits ideas and justification for improved systems and tools to leadership.
- * if acts as line manager, the following responsibilities apply*:
- line management responsibilities for the training, utilization, development, and performance of central monitoring and/or medical data review operations staff.
- assign and classify tasks to the employees.
- supervise, mentor, and evaluate performance of staff to ensure career development, interpersonal skills, and achievement of competency standards.
- looking after the workforce’s hr needs.
- assist in recruitment of new staff.
- budgeting and scheduling for work force required to perform tasks.
- ensure the smooth functioning of department in the organization.
- responsible for managing performance review and issues of direct reports.
- all other duties as needed or assigned.
*qualifications (minimum required)*:
- university / college degree or post-graduation from an appropriately accredited institution.
- fortrea may consider relevant and equivalent experience in lieu of educational requirements.
*experience (minimum required)*:
- minimum of 7-9 years of relevant clinical research experience in a pharmaceutical company/cro or other equivalent experience with increasing levels of responsibility in clinical trial related roles e.g., project management, clinical monitoring, data management and informatics.
*preferred qualifications include*:
- university / college degree or post-graduation in life science preferred.
*physical demands/work environment*:
- standard office or home working equipment required.
- * travel requirements*:
- local, domestic, global.
- * identify the expected travel requirements of the position on an annual basis*:
- % of time:15%.
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