Clinical Data Reviewer – Oncology

🔥 4 minutes ago

🌵 Arizona, Maine, +2 more states – Remote

🌵 Arizona – Remote 🦞 Maine – Remote 🏈 Ohio – Remote ⚓ Rhode Island – Remote

💵 $80.6k - $145k / year

⏰ Full Time

🟠 Senior

🔴 Lead

🔍🏥 Medical Reviewer

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Syneos Health

WebsiteLinkedInAll Job Openings

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. By utilizing advanced technologies and insights, Syneos Health collaborates with clients to speed the delivery of important therapies to patients worldwide, offering services that span the entire clinical-to-commercial spectrum.

📋 Description

• Ensure data readiness for important milestones including, but not limited to, interim analysis, final analysis, snapshots to support submissions, Data Monitoring Committee reviews and publications • Review participant level data across a study in adherence with CRF Completion guidelines (CCGs) and the Data Review Plan (DRP) • Conduct point-to-point data checks (e.g. verifying the presence of a lab test that satisfies study inclusion criteria) and interpretive analysis (e.g. reviewing to identify inconsistencies in the participant’s data). • Generate queries on discrepant data and follow to resolution including escalation of issues that cannot be resolved through the query process • Create and use data review best practices and associated data review tools to identify trends and any safety signals • May identify protocol deviations during routine clinical review and escalation as appropriate • Follow relevant SOPs and regulations, have an excellent understanding of and comply with applicable training requirements, constantly seeking further improvements in quality and efficiency of clinical procedures • May liaise with data management, clinical and site management along with other members of the study team • Attend Clinical Meetings and Study Me

🎯 Requirements

• Bachelor’s degree or nursing degree is preferred. • At least 7 years of clinical research experience in the pharmaceutical industry (Strong monitoring experience is a plus) • 3+ years experience of oncology experience. • Direct clinical review and query writing/resolution experience required • Prior EDC experience preferred • Proficient in reviewing large scale listings in Microsoft Excel format (filter, sort, data format (date). • Basic understanding of how data points from different fields/CRFs interact and how data collection impacts analysis • Ability to work independently in a virtual setting and as part of a remote team • Ability to prioritize and adjust work priorities quickly as needed to meet deadlines (i.e. fluid, flexible work style) • Possess basic knowledge of data management including case report form design, workings of electronic edit checks, implementation of data handling conventions and interpretation of data status reports • Good written and oral communication skills with strong attention to detail required meetings, as necessary.

🏖️ Benefits

• Health benefits to include Medical, Dental and Vision • Company match 401k • Eligibility to participate in Employee Stock Purchase Plan • Eligibility to earn commissions/bonus based on company and individual performance • Flexible paid time off (PTO) and sick time • Company car or car allowance