Job Description

OverviewResponsible for ensuring high quality medical review of phase I-III clinical trial data in the field of oncology, neurology and immunology, in compliance with GCP/ICH and regulatory requirements.Provide high quality, timely and diligent clinical data review to ensure adequate data quality for the successful completion of clinical trials and regulatory submissions.Qualifications

• 5+ years experience in pharmaceutical industry or clinical research organization or health care experience, as a Medical Data Reviewer, Medical Monitor or similar roles. Basic knowledge in planning, executing, and reporting global clinical studies.
• Fundamental knowledge of GCP/ICH guidelines, clinical trial design, medical data review, statistics, regulatory processes, and drug development processes in oncology, neurology and/or immunology.

Demonstrates knowledge and application of statistical analysis methodology and can identify trends, as well as analyzing, interpreting, and reporting data effectively.xc3x98 The Medical Data Reviewer in close collaboration with Medical Lead and/or Clinical Research Scientist sets up and coordinates the medical data review process, assists with medical data review and manages medical queries. Specifically, the Medical Data Reviewer ensures that the data is comprehensive from a medical point of view across different studies and projects and supporting interim analysis, database and post lock activities and facilitate resolution of clinical data issues.xc3x98 Conducts medical review of the data as per Medical Data Review Plan on incremental listings and patient profiles in close collaboration with Medical Lead and/or Clinical Research Scientist, using pre-established criteria to assure that patient data is compete and medically plausible and to clarify inconstancies and missing events. Data listings and patient profiles will be reviewed for plausibility and consistency. Reviews data for protocol deviations. Raises queries to the sites, follows them until resolution and documents the medical review according to Medical Data Review Plan.xc3x98 Good communication skills - verbal, written and listeningxc3x98 Proven analytical and organizational skills with a strong attention to detail, and the ability to interpret large volumes of complex data.xc3x98 Participates in internal and external relevant meetings, as needed.xc3x98 Inherit experience in clinical databases, industry techniques and standards. Provides input into the electronic Case Report Form (eCRF) and CRF Completion Guidelines, edit checks, Medical Data Review Plan and related relevant documents as needed.xc3x98 Knowledge of patient profiles and data listings. Aptitude to interpret medical history and clinical information, including cancer diagnosis, treatment options and clinical safety and efficacy data (RECIST 1.1 assessment, CTCAE grading other relevant criteria).xc3x98 Collaborate with relevant functions to improve the quality of clinical data review/insights with an emphasis on subject safety and eligibility, efficacy endpoints, data integrity, trend identification, analysis and remediation, and identification of cases for medical review.xc3x98 Assist in the development and monitoring of the data review strategy, ensuring that critical clinical data review findings are adequately implemented and resolved, leading to a front-loaded data cleaning and high quality study data.xc3x98 If applicable, the Medical Data Reviewer may support writing patient narratives or uploading essential documents related to their task to the electronic Trial Master File.

• Degree in a medical profession or life sciences (physician, nurse, pharmacist, scientist) is required. PhD, MBBS, BDS, MD strongly preferable. Proficient English (oral and written).
• Experience in oncology, neurology and/or immunology

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