Medical Data Review Manager - Rheumatology

JOB SUMMARY:

Responsible for medical data review.

Performs review of medical data to ensure medical/scientific plausibility and to employ medical assessment and knowledge. Also, provides medical expertise in assigned trials.

ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:

Attend and present Medical Data Review activities during the client Kick Off Meeting

Write Medical Data Review Plan in collaboration with the Medical Monitor and in accordance with the client input

Create protocol specific Medical Data Review Guide in collaboration with the Medical Monitor

Participate in the internal eCRF review meeting and contribute to the development of eCRF

Define data capture requirements as required throughout the study that are consistent with the protocol and reporting needs

Contribute to the Data Review Plan

Provide requirements and specifications for programming of data listings

Collaborate with Clinical Science and Data Operations teams in the development of Qlik Sense builds and protocol specific customizations for patient profiles

Participate in activities involving risk assessment and measuring the effectiveness of risk minimization measures

Provide medical review of data listings and patient profiles, including but not limited to, adverse events, concomitant medications, medical history, labs, vitals, ECGs, eligibility criteria, efficacy assessments and study specific assessment.

Compose the STAR report during the study according to scope and timelines

Conduct in-stream data trend analysis in support of data quality and integrity including protocol compliance and targeted review of patient data

Prepare periodic MDR summary reports or presentations if requested

Medical review and case assessment of SAEs including assessment and coding of preferred term, medical history, indications of concomitant medications and treatment medications; determination of seriousness, causality, expectedness; narrative review; query generation and follow up of SAE till case closure

Compose sponsor comment/summary

Compose, edit, and medically review Analyses of Similar Events (AOSE) for expedited cases as appropriate based on regulatory requirements

MINIMUM REQUIRED EDUCATION AND EXPERIENCE:

Medical degree with Rheumatology certification.

Recipient of a medical license from the country or region in which he/she currently resides or previously resided, or if in the US recipient of a license to practice medicine as a physician assistant or nurse practitioner

5 years’ experience in the practice of medicine in a clinical or academic setting which may include specialty medical training or fellowship

Minimum of 3 years’ experience in Medical Data Review.

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