Medical Data Reviewer

Role Overview

Clinical Data Review

• Review clinical and medical patient data and documents to identify errors requiring clarification with study sites.
• Review eligibility, diagnosis, medical history, prior treatments, study-drug administration, adverse events, concomitant medications, safety labs, efficacy assessments, coding, and study milestones.
• Issue clinical data queries, follow up on site responses, and close or re-query issues as appropriate.
• Conduct in-stream data trend analysis, targeted patient-data review, and protocol-compliance review.

Data Quality and Site Support

• Monitor site data-entry performance, identify root causes of data issues, and implement remedial actions.
• Communicate training needs for CRAs and sites and contribute to electronic data capture completion training.
• Ensure timely follow-up and resolution of data-related compliance issues and improve the efficiency and quality of deliverables.

Meetings and Deliverables

• Participate in protocol-deviation, data-review, statistical-review, safety-monitoring, and other clinical data review meetings.
• Prepare or review materials for investigator meetings, advisory boards, safety reviews, management meetings, and study decision discussions.
• Review and quality-check clinical data sections, abstracts, manuscripts, presentations, patient narratives, and clinical study report materials.

Cross-Functional Collaboration

• Collaborate with clinical scientists, medical directors, data management, and clinical operations before data cuts, interim analyses, regulatory requests, site close-outs, and final database lock.
• Support clinical data project management, audit readiness, clinical compliance, and systems-validation compliance.

Education and Experience

• A medical degree or advanced healthcare qualification, such as MD, MBBS, PharmD, nursing degree, or equivalent, is accepted.
• A life-sciences degree with relevant clinical experience is also accepted.
• At least five years of pharmaceutical clinical or medical data review experience, including clinical cross-check experience, is required.
• Eight or more years of experience is preferable. Experience with solid tumor oncology is required.

Required Capabilities

• Experience in clinical research, pharmacovigilance, or medical monitoring is preferred, particularly in a CRO, pharmaceutical, or related environment.
• Strong knowledge of clinical trial design, Good Clinical Practice, safety reporting, and medical terminology is required.
• The role requires analytical ability, attention to detail, English communication, organization, operational skills, and the ability to meet timelines.
• Experience with coding review, query writing, clinical databases, electronic data capture systems, listings, standard data formats, Microsoft Excel, and project management is required.
• The role requires independent work and effective collaboration in cross-functional, global teams.

Workplace

• The position is India-based and home-based.

Benefits

• Benefits may include annual leave, health insurance, retirement planning, life assurance, employee assistance, and country-specific optional benefits.
• ICON states that it supports an inclusive workplace and reasonable accommodations for candidates with disabilities or medical conditions.