Medical Data Reviewer

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 you will be doing**:
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.
- 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 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.

**Required Experience and Skill Set**:

- 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

**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 maximise savings and plan with confidence for the years ahead
- Global Employee Assistance Programme, TELUS Health, 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, b