11 Sep
|
Fortrea
|
Bengaluru
Job Overview:
Responsible for the execution of key central monitoring (site, subject and study level review as applicable) activities. Collaborates within a matrix setting, 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 r
📌 Central Monitoring Associate Manager (Bengaluru)
🏢 Fortrea
📍 Bengaluru