ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success.
Post : Medical Data Reviewer
Job Description
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 Client 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.
o 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: o Protocol Deviation review o Data Review and Quality Team (DRQT) o Statistical Review of Clinical Data (SRCD) o Safety Monitoring Team (SMT) review o Slide preparation of top-line results
• May be involved in preparing or review material for and presents in data dissemination meetings, such as: o 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 Client 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.
Candidate 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.
Additional Information
Experience : ≥ 5 years
Qualification : MD, PharmD, PhD, Nursing degree, MSc
Location : India
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Medical & Scientific Affairs
End Date : 25th May 2024
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