Medical Data Reviewer in Bangalore, भारत

Medical Data Reviewer - Remote, Home-Based

At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s global expertise.

As the world’s largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.

As a Senior Medical Data Reviewer at ICON, you will provide expert medical oversight of clinical trial data, ensuring accuracy, consistency, and patient safety. You will support complex programmes, mentor colleagues, and contribute to the development of robust medical review practices.

What You Will Do:

As a subject matter expert, the Medical Data Reviewer is responsible for ensuring high quality medical review of phase I-III clinical trial data in the field of oncology, neurology and immunology or other therapeutic areas of interest, in compliance with GCP/ICH and regulatory requirements.

• The Medical Data Reviewer works in close collaboration with the Medical Lead and/or Clinical Research Scientist to set up and coordinate 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 database milestones (such as interim analysis, DMCs or Health Authority interactions), database and post lock activities and facilitate resolution of clinical data issues.

• 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 complete and medically plausible and to clarify inconsistencies and missing events. Data listings and patient profiles (as well as data visualization tools) will be used to review for plausibility and consistency. Reviewing data for protocol deviations. Raising queries to the sites, and following them until resolution and documenting the medical review according to Medical Data Review Plan.

Your Profile:

• More than 2 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.
• Proven analytical and organizational skills with a strong attention to detail, and the ability to interpret large volumes of complex data.
• Good communication skills - verbal, written and listening
• Educational and/or work experience in the respective therapeutic area (e.g. Oncology, Neurology and/or Immunology) preferred
• Experience in analysis and interpretation of clinical data and a working knowledge of biostatistics, ICH-GCP, and regulatory requirements for clinical studies.
• Proficient English in written/verbal communication and presentation skills.
• Participates in internal and external relevant meetings, as needed.
• 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.
• 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).
• 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.
• 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.
• 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

Qualifications:

• Degree in a medical profession or life sciences (physician, nurse, pharmacist, scientist) is required. PhD, MBBS, BDS, MD strongly preferable .

What ICON can offer you:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

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