Hybrid Medical Data Reviewer Job at ICON

Are you looking for a Medical Data Reviewer role in Bangalore, Bengaluru? This Medical Data Reviewer Job at ICON Strategic Solutions (FSP) can be remote or office-based and requires a medical or life sciences degree with relevant clinical experience. 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, ICON Strategic Solutions offers stability, career development and a collaborative environment. Your work contributes to the development of treatments that benefit patients worldwide.

About ICON Strategic Solutions:

ICON Strategic Solutions is a specialised business division of ICON plc, a leading global Contract Research Organisation (CRO). It provides Functional Service Provision (FSP) solutions to pharmaceutical, biotechnology, and medical device companies worldwide. The division supports various areas of clinical research, including clinical trial management, pharmacovigilance, clinical data management, medical writing, regulatory affairs, and biostatistics. Through strategic partnerships, advanced technologies, and experienced professionals, ICON Strategic Solutions helps organisations streamline clinical development, improve research efficiency, and accelerate the development of innovative medicines.

Job Details:

Job Title: Medical Data Reviewer
Location: Bangalore, Bengaluru
Work Mode: Remote or Office
Category: Medical Data Review
Job Reference: JR157555

Key Responsibilities:

Serve as a Clinical Data Reviewer and identify any errors in data by performing data review that require further clarification with the study site.
Perform ongoing review of clinical/medical aspects of assigned patient data and documents (escalates to Regeneron Clinical Scientist and/or medical monitor, as appropriate)
Examples include, but are not limited to: patient eligibility, diagnosis, medical history and prior treatments, study drug administration, AEs/SAEs/AESIs, concomitant meds, safety labs, efficacy assessments, EOT, EOS, survival, coding, etc.
Issues clinical data queries and ensures timely follow-up following site responses as to whether the queries are appropriately addressed, and updates in EDC are done, if applicable, by either closing out the queries or re-querying, as applicable
Communicates any data training needs for CRAs, sites, etc.
Conduct in-stream data trend analysis in support of data quality and integrity (includes protocol compliance and targeted review of patient data)
Provide clinical data Project Management and be viewed as an expert in data clinical/medical review and cleaning.
Ensure a data-quality focus for audit readiness with Clinical Compliance and Systems Validation Compliance.
May assist in reviewing and contributing to guidance on data capture requirements in line with protocol and reporting requirements.
Monitor site data-entry performance and provide leadership in identifying root causes of data issues and implementing remedial actions.
Ensure timely follow-up and resolution of data-related compliance issues.
Continuously assess opportunities to improve efficiency of tasks and quality of data deliverables. May contribute to EDC completion training.
May participate in clinical data review meetings such as: Protocol Deviation review; Data Review and Quality Team (DRQT); Statistical Review of Clinical Data (SRCD); Safety Monitoring Team (SMT) review; Slide preparation of top-line results
May be involved in preparing or reviewing material for and presenting in data dissemination meetings, such as: Investigator meetings, advisory boards, safety cohort review meetings, IDMC, SC, senior management meetings, central imaging review, CST/SPT/DPR/PRC discussions for study/program decisions
May be involved in review and QC of clinical data sections for abstracts/manuscripts/ oral and poster presentations
Will collaborate closely with Regeneron Clinical Scientists, Medical Directors, Data Management and Clinical Operations to execute clinical data reviews and activities prior to data cuts for snapshots, interim analysis, DSUR, IBs, regulatory requests, study site close-outs and final DBL.
May be closely involved in data review and identification of readiness for clinical narratives for Clinical Study Report (CSR)
May be involved in QC review of patient narratives and contribute to tracking of such.

Eligibility Criteria for the Medical Data Reviewer Job:

Medical degree or advanced healthcare qualification (e.g., MD, MBBS, PharmD, or equivalent), or a life sciences degree with relevant clinical experience.
Experience in clinical research, pharmacovigilance, or medical monitoring, preferably within a CRO, pharma, or related environment.
Strong understanding of clinical trial design, GCP, safety reporting, and medical terminology.
Excellent analytical skills and attention to detail, with the ability to interpret complex clinical data.
Good communication and collaboration skills, with the ability to work effectively in cross-functional, global teams.
Comfort working with electronic data capture systems, listings, and standard data formats.

Required Skills for the Medical Data Reviewer Job:

Educational scientific background such as MD, PharmD, PhD, Nursing degree, MSc
≥ 5 years of pharmaceutical clinical/medical data review experience is required, including clinical crosscheck experience. 8+ years is preferable.
Experience with Solid Tumour Oncology
Excellent verbal and written communication in English, organisation and tracking skills. Strong operational skills and demonstrated ability to meet timelines.
Detail oriented
Experience in coding review
Query writing training
Strong clinical database navigation skills
Strong MS Excel, project management
Proven ability to work independently and in a team setting.
Knowledge of Good Clinical Practice; comprehensive knowledge of clinical trial design; understanding of the overall drug development process

Additional Information:

Benefits include,

Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs.
Competitive retirement planning offerings to maximise 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 specialised 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, subsidised travel passes, health assessments, among others.

Hybrid Medical Data Reviewer Job at ICON, Bangalore | Medical & Nursing Professionals Apply!