▷ [Immediate Start] Medical Data Reviewer

4 weeks ago

Bengaluru, India ICON plc Full time

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 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

Preferred 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

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