Medical Data Reviewer - India, Home-Based

ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

What Will You Do

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 not limited to: Patient eligibility, diagnosis, medical history and
prior treatments, study drug administration, AE/SAE/AESI, con meds, safety labs,
efficacy assessments, EOT, EOS, survival, coding, etc.
Issues clinical data queries and ensure timely follow up following site responses as to whether the queries are appropriately addressed, and updates in EDC 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 viewed as an expert in data clinical/medical review and cleaning.
Ensure data quality focus to audit readiness with Clinical Compliance and Systems Validation Compliance.
May assist in review and contribute to data capture requirements guidance in line with protocol and reporting requirements.
Monitor site data entry performance and provide leadership to identify root causes of data issues and implement 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 review material for and presents 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 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.

Your Profile

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 preferrable.
Experience with Solid Tumor Oncology
Excellent verbal and writing communication in English, organization 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

Required Qualifications And Experience

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.

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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