Perform reports providing critical analysis of the data reviewed. Escalate and follow-up issues for prompt resolution.Acting as connector between sponsor requests, Clinical Monitoring Leads, and sites.

Perform centralized monitoring activities on assigned projects and evaluate the quality and integrity of the study as per the protocol requirements.Main point of contact with sites to provide guidance, training, and support. Leading Monthly Callsand Remote Monitoring visits to follow up the site status.Interaction with sites/CRA and follow-up on study required milestones from the project.Perform Subject Level Data Review.

Serve as key point of contact for a large customer/sponsor portfolio, maintain/enhance relationships and provide regulatory advice where needed.Build and run global transparency reports based on customer’s requirements to be submitted to various government bodies by the sponsorWork directly with project teams to validate data where needed while also analyzing trends in incomplete data to raise with upper management to meet and improve processes to drive efficiencies.

Serve as key point of contact for a large customer/sponsor portfolio, maintain/enhance relationships and provide regulatory advice where needed.Build and run global transparency reports based on customer’s requirements to be submitted to various government bodies by the sponsorWork directly with project teams to validate data where needed while also analyzing trends in incomplete data to raise with upper management to meet and improve processes to drive efficiencies.

Ensure effective security, storage, and retrieval of all proprietary and client information in accordance with established procedures. Includes usage of scanning equipment.Conduct imaging/scanning and train on imaging/scanning processesMaintain log and enter metadata in database to track status and facilitate accurate retrieval of information.File, maintain and process reports, collections, and validations.

Assist the clinical team in the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures. Assist with periodic review of study files for accuracy and completeness.Act as a central contact for the clinical team for designated project communications, correspondence and associateddocumentation.Perform assigned administrative tasks to support team members with clinical trial execution.