Job Overview:
Responsible for the execution of key central monitoring (site, subject and study level review as applicable) activities. Collaborates within a matrix environment, communicates proactively internally and externally and across functions with key stakeholders to ensure Central Monitoring is proactively and effectively executed to meet client expectations. May be responsible for the preparation and conduct of Central Monitoring tasks across a series of sponsor projects commencing with Informatics platform launch up to study reporting. Conducts review of the applicable Informatics platform and communicates findings at the country, study, site, subject level. Provides Central monitoring support to the study team and to the client. Requires working knowledge of broader drug development and clinical trials. The role is responsible for the conduct of central monitoring activities in a timely manner. Oversee the trial progress as per the defined plan and notify any changes/risk and escalate as appropriate.
Summary of Responsibilities:
- Performs the Central monitoring activities for multiple studies for customers and ensures accurate tracking and status reporting of studies in their remit.
- Act as the Lead for the Central Monitoring team for more than one studies for multiple customers.
- Support Manager and leadership in preparation of detailed study risk assessment and in Sponsor presentations / bid defenses.
- Ensures that tracking and status reporting are performed in a timely and accurate manner.
- Contributes to the Risk Assessment and Categorization Tool (RACT) for topics related to central Monitoring and/or medical reviews and considers risks when planning tools configuration.
- Supports the Data Expert with Critical Data and Process Definition and EDC design implementation.
- Supports the development of informatics Platform requirements, including design of the visualizations, taking into consideration the data feeds for the study (EDC, laboratory, etc.).
- Collates requirements including prescriptive risk factor mitigation strategies, SDV strategy, study-specific risk factor definition, variable risk factor trigger levels.
- Draft the Configuration Plan and all other applicable Plans in collaboration with the study team and update these on an ongoing basis including the refinement of visualizations and any edits in line with emerging risk profile and study changes.
- Edits the Central Monitoring and other applicable plans in line with emerging risk profile and study changes.
- Populates the tools, tests variable risk factors, adjusts trigger levels, study specific risk factors and central monitoring parameters.
- Performs ongoing reviews, prepares, and recommends mitigation actions and reviews recommended monitoring levels with project team and ensures that identified issues are followed to resolution.
- Proposes potential changes to monitoring intervention level on behalf of the project team in line with overall strategies.
- Prepares and distributes the Project/Study Reports at intervals during study conduct and at study close out.
- Undertakes Central Monitoring (Site, subject and study level review as applicable) activities to ensure consistency and effectiveness.
- Take responsibility for inspection readiness for activities; support regulatory authority inspections when needed.
- Perform subject level review activities and coordinate with the stakeholders to address the findings if applicable.
- Performs study analytics reviews as per the applicable plans and communicates the findings appropriately.
- Provide data-driven decisions and communicate these findings proactively and effectively to the key stakeholders.
- Prepares and distributes the Project Quality and Risk Reports at intervals during study conduct and at study close out.
- Performs specialized review of central data review tools, based on specific area of expertise (clinical, data or statistics).
- Implements P3 thinking to identify the need for study scope changes and risk profile changes.
- Provides technical leadership to study teams to ensure effective implementation of the process and tools.
- Evaluates and collates process improvement suggestions and submits to leadership.
- Evaluates and submits ideas and justification for improved systems and tools to leadership.
- Submits ideas to increase sales by positioning central monitoring and Informatics Platform with clients.
- 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 work force’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 from an appropriately accredited institution.
- Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
Experience (Minimum Required):
- Minimum of 6-8 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:
- Post-graduation in Life sciences or any other applicable qualification and experience.
Physical Demands/Work Environment:
- Standard office or home working equipment required.
Travel Requirements:- Global.
- % of time:15%
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