Job Title: Medical Data Reviewer (4 to 6 months Contract)
Job Location: India ( Remote)
Job Overview:
The Medical Data Reviewer is responsible to perform Medical data review, focused on relevant safety and efficacy parameters, as defined in the Medical Data Review Plan (MDRP) developed for each project in which these services are performed by Caidya. If the scope of data review is limited (e.g., coding review), the Medical tasks may be included only within the Medical Monitoring Plan (MMP) or equivalent document. The Medical Data Reviewer may also perform other associated tasks, as indicated, such as query formulation and review for closure, documentation of reviews, and/or completion of summary reports.
Job Duties and Responsibilities:
Job duties differ from project to project and are described in the contract, project-specific Plans (e.g. MMP; MDRP), and/or other documents agreed with Sponsor/Client. Job duties also comprise any other tasks as defined by applicable Policies/SOPs/Work Procedures (WPs) and in general include but are not limited to the following:
? Performance of medical data review tasks to ensure applicable SOPs/Guidelines, Sponsor/Client directives, and GCP guidelines are followed;
? Review and input into the design of eCRF fields relevant to Medical data review for the project(s);
? Development, input, and/or review of the project-specific Medical Data Review Plans (MDRPs) or equivalent document;
? Implementation of Medical data review tools, including but not limited to listings, patient profiles, and visual analytic templates;
? Review and/or input into the review of the following types of Medical data:
? Vital signs;
? Physical examination results;
? Laboratory tests;
? ECG results;
? Imaging results;
? Adverse events, serious adverse events, and or Dose Limiting Toxicities (DLTs);
? Concomitant medications;
? Past medical history;
? Protocol deviations requiring Medical review;
? Efficacy assessments;
? Other types of Medical data, as specified per project
? Generation, review and/or input into the review/closure of Medical queries;
? Preparation of project-specific reports;
? Training of new team members in Medical data review processes, goals, and tools, as requested;
? Attendance at internal and external (include Sponsor/Client and/or non-Caidya personnel) project specific meetings, if requested;
? Attendance at data review meetings (interim analysis and final data analysis), if requested;
? Review of Medical Coding to assure medical reasonability of the codes and re-coding items if it is appropriate;
? Documentation of significant communication (interactions with sites, Sponsor/Client, internal team members and external parties etc.) as required;
? Other tasks and responsibilities as assigned.
Additional Tasks and Responsibilities (as needed)
? Work with staff and project teams on integrated data review, as opportunities arise, providing expertise on medical data;
? Work closely with other functional groups and departments including but not limited to Safety/Pharmacovigilance, Project Management, Clinical Operations, Data Management, Biostatistics and QA to ensure that medical data review functions are executed effectively as per contract;
? Take part in meetings with existing and potential clients, if requested.
Supervisory Responsibilities:
No supervisory responsibilities.