Centralised Clinical Team Lead II

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Individual Contributor

Trip Report Review responsibilities:
Reviews trip reports and works closely with project teams towards implementation of best trip report practices; revising applicable project plans where needed. Proactively identifies risks in the trip reports and communicates any trends, outstanding issues, safety concerns to the study team. Ensures that identified issues are followed till resolution. Acts as liaison between CRA, CTL and PM for timely resolution of issues. Trains and mentors CRAs and IHCRAs on trip report writing and monitoring activities, where needed. Responsible for Trip report templates and guidelines creation, Document Review, eTMF reconciliation, protocol deviation review and trending analysis, Issues management, PSV/SIV slide deck creation and other given CTL tasks. Supports study team for CQC visits, Quality Events, and other ad hoc tasks, where needed. Mentoring and training of new cCTL on trip report review processes as per ICH-GCP and SOPs and local work instructions. cCTL-II is also the main point of contact for communication with the Global CTLs/PMs

Central Monitoring responsibilities:
Acts as lead for a study and oversees Central monitoring activities for multiple studies. Oversees and supports the central monitoring teams on the delivery and ensure accurate tracking and status reporting of studies. Develops and establishes requirements including prescriptive risk factor mitigation strategies, SDV strategy, study-specific risk factor definition, variable Risk Factor trigger levels and supports Manager in preparation of detailed study risk assessment and in Sponsor presentations / bid defenses. Contributes to the Risk Assessment and Categorization Tool (RACT) for topics related to central Monitoring. Supports the development of the Critical Data and Critical Process Definitions. Supports the development of informatics Platform requirements that include design of the visualizations, taking into consideration the data feeds for the study (EDC, laboratory, etc.). Drafts Configuration Plan, Central Monitoring Plan and any other relevant Plans in collaboration with study team. Updates these on an ongoing basis including refinement of visualizations and any edits in line with emerging risk profile and study changes. Undertakes Central Monitoring activities (Site, region & study level review as applicable) and performs study analytics reviews as per the applicable plans. Provides data-driven decisions, communicates findings proactively and effectively to the key stakeholders as per defined timelines. Performs ongoing reviews, prepares and recommends mitigation actions along with reviewing recommended monitoring levels. Proposes potential changes to monitoring intervention level. Populates the tools, tests variable risk factors, adjusts trigger levels, study specific risk factors and central monitoring parameters. Prepares and distributes the Project quality, Study and risk Reports during study conduct as per defined timelines.

General:
Manages projects under direction of a Project Manager/Director as assigned and responsible for timely and appropriate communication to the clinical operations team. Oversee site monitoring responsibilities for clinical studies are conducted according to Fortrea Standard Operating Procedures, ICH Guidelines and GCP. Follows applicable departmental Standard Operating Procedures and Work Instructions. Follows project issue escalation process and Fortrea Corrective action issue resolution process for clinical operations issues. Proactively identifies opportunities for process improvements and works collaboratively with project team in case further action required. Completes required trainings within timelines and ensures training resources are up to date with changes in procedures. Provides technical leadership to study teams to ensure effective implementation of the process and tools to identify the need for study scope changes and risk profile changes. Supports study team with inspection readiness activities; supports regulatory authority inspections when needed. Supports clinical project team in ensuring effective cross functional teamwork among project team members including both internal and external stakeholders. Evaluates and submits to leadership ideas for process/system/tools improvements along with justification. Reviews and supports development of training material (as instructed) and plans to support the training requirements of the department. Support in review of standard operating procedures or work instructions to align with process or tool modifications.

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