ICON Strategic Solutions is inviting applications for the position of Medical Data Reviewer in India. This is a full-time opportunity with remote/home-based work options, listed under Bengaluru, Karnataka.
Candidates with medical, pharmacy, nursing or life sciences qualifications and more than 2 years of experience in the pharmaceutical industry, clinical research or healthcare can apply.
The role involves medical review of Phase IβIII clinical trial data, patient profile assessment, clinical data validation, medical query management and ensuring patient safety across therapeutic areas such as oncology, neurology and immunology.
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Job Details
| Particulars | Details |
|---|---|
| Company | ICON Strategic Solutions |
| Job Role | Medical Data Reviewer |
| Job ID | JR156093 |
| Location | Bengaluru, India |
| Work Mode | Remote / Home-based |
| Remote Type | Office or Home |
| Employment Type | Full-time |
| Experience | More than 2 years |
| Therapeutic Areas | Oncology, Neurology, Immunology |
| Job Category | Clinical Research / Medical Data Review |
Position
– Medical Data Reviewer
Job Responsibilities
- Conduct medical reviews of Phase IβIII clinical trial data across oncology, neurology, immunology and other therapeutic areas.
- Collaborate with Medical Leads and Clinical Research Scientists to establish and coordinate medical data review processes.
- Review patient profiles and incremental data listings to identify inconsistencies, missing events and medically implausible information.
- Manage medical queries and coordinate their resolution with clinical trial sites.
- Review clinical trial data for protocol deviations and document findings according to the Medical Data Review Plan.
- Support database milestones, including interim analysis, Data Monitoring Committee (DMC) activities and Health Authority interactions.
- Ensure clinical data completeness, accuracy and consistency.
- Support database lock and post-lock activities.
- Contribute to the development of eCRFs, CRF Completion Guidelines, edit checks and Medical Data Review Plans.
- Identify clinical data trends and support data cleaning and remediation activities.
- Collaborate with cross-functional teams to improve patient safety, subject eligibility, efficacy endpoints and data integrity.
- Assist in writing patient narratives and uploading essential documents to the electronic Trial Master File (eTMF), where applicable.
Eligibility / Qualifications
Candidates should meet the following requirements:
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- Degree in a medical profession or life sciences.
- Relevant educational or professional background in medicine, nursing, pharmacy or science.
- More than 2 years of experience in the pharmaceutical industry, CRO, healthcare or similar Medical Data Reviewer / Medical Monitor roles.
Preferred Qualifications:
- PhD
- MBBS
- BDS
- MD
Required Skills
- Knowledge of ICH-GCP guidelines and clinical trial regulations.
- Understanding of clinical trial design and drug development.
- Medical data review and clinical data interpretation.
- Knowledge of biostatistics and statistical analysis methodologies.
- Ability to interpret large volumes of complex clinical data.
- Understanding of patient profiles and clinical data listings.
- Knowledge of medical history, cancer diagnosis and treatment options.
- Understanding of RECIST 1.1 assessment and CTCAE grading.
- Experience with clinical databases and industry standards.
- Knowledge of clinical safety and efficacy data.
- Strong analytical, organizational and communication skills.
- Excellent written and spoken English.
- Understanding of eCRF, CRF Completion Guidelines and Medical Data Review Plans.
What ICON Offers
- Competitive base salary.
- Performance-related incentives.
- Medical, dental and vision coverage, where applicable.
- Retirement and pension plans.
- Life assurance and disability coverage.
- Employee assistance programmes.
- Health and wellbeing resources.
- Learning and development opportunities.
- Structured training and career pathways.
