Job Title: Medical Data Reviewer

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.

Job Requirements:

• Education

  • Physician Assistant, MBBS/MD, Nurse Practitioner (or country-specific equivalent) required

• Experience

  • At least 1 year of clinical experience post-degree and at least 2 years of experience in the Pharmaceutical, Biotech, Medical Device and/or CRO industry working with clinical data.

  • Highly desirable:

    • Experience of working in a Medical or drug development environment performing medical data review using visual analytics programs (e.g., Spotfire, J-Review, Tableau, Qlik Sense, Power BI).

    • Experience implementing Medical data review templates for complex data sets.

    • Experience in oncology studies.

• Skills/Competencies

  • Clinical thinking: ability to use data review tools, to perform designated review of safety and efficacy data, and to formulate good queries; ability to understand data collection in project specific documents to optimize oversight of patient safety, data integrity and successful completion of project;

  • Deep understanding of the scientific basis for therapies and pathology induced by disease states;

  • Deep understanding of clinical databases and visual analytic templates;

  • Strong knowledge of the drug/device/vaccine development process;

  • Understanding of ICH GCP, applicable regulatory requirements for study data, good documentation practices;

  • Time management: good sense of urgency, prioritization skills;

  • Team player: effective participant as a team member and team leader;

  • Attention to detail;

  • Creative problem-solving skills;

  • Effective oral and written communication and presentation skills (at least in English) are compulsory; ability to clearly and efficiently communicate with site and team members both inside and outside to company; development and delivery of the trainings and presentations;

  • Integrity: Understanding and acting on principles of honesty, trust and fairness.

• Capabilities

  • Proficient in the use of computers and EDC programs.

  • Ability to drive an automobile and have a valid driver’s license.

  • Must have a credit card that can be used for travel expenses.

  • Ability to work remotely.

  • Ability to travel up to 10 %, if needed.