Clin Ops Delivery Specialist II - (Central Review Mgr)

Job Description

Performs review of clinical monitoring visit reports for allocated projects ensuring consistency across protocols and/or regions and escalates any protocol, site, and/or CRA issues or trends noted during the report review process to CTM. Liaises with clinical monitoring staff for prompt trip report review submission and approval as per the stipulated timelines of PPD and/or the Sponsor. Plays an active role on the project team to help ensure compliance with monitoring visit report expectations. Reviews and customizes the Monitoring Report Templates for allocated projects. Evaluates PI oversight (e.g., protocol adherence), subject safety and study processes in order to assess site’s ability to conduct study, as ascertained from information noted in monitoring visit reports and associated electronic data systems. Attends applicable internal Project meetings. Provides input of forecast estimates for report review activities. Provides trial MVR status tracking and progress update reports to team as required. Contributes to company, client, and federal/local regulatory requirements/audit responses as needed. May perform support activities to the team as agreed on allocated projects.