Clinical Data Reviewer analyzing oncology trial data for Syneos Health’s integrated life sciences services. Ensuring data readiness, resolving queries, and identifying safety signals across clinical studies.
Responsibilities
Perform clinical review ahead of significant project milestones, including interim analysis, study closeout, and submission
Ensure data readiness for interim and final analyses, submission snapshots, Data Monitoring Committee reviews, and publications
Review participant-level data across studies according to CRF Completion Guidelines and the Data Review Plan
Conduct point-to-point data checks and interpretive analysis to identify inconsistencies
Generate queries on discrepant data and follow them through resolution, escalating unresolved issues
Create and use data review best practices and tools to identify trends and safety signals
Identify and escalate protocol deviations during routine clinical review
Follow applicable SOPs, regulations, and training requirements while improving clinical procedure quality and efficiency
Liaise with data management, clinical and site management, and other study team members
Attend clinical meetings and study meetings
Requirements
Sr CRA or CTM experience with Oncology is required
Candidates must reside in US or Canada with no sponsorship needs
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
Direct clinical review and query writing/resolution experience required
Sufficient clinical knowledge to assess whether participant data is scientifically and clinically valid
Prior EDC experience preferred
Proficient in reviewing large-scale listings in Microsoft Excel format, including filtering, sorting, and date formatting
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 to meet deadlines
Basic knowledge of data management, including case report form design, electronic edit checks, data handling conventions, and data status reports
Good written and oral communication skills with strong attention to detail
Benefits
Career development and progression
Supportive and engaged line management
Technical and therapeutic area training
Peer recognition and total rewards program
Company car or car allowance
Medical, Dental and Vision health benefits
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
Reasonable accommodations for applicants and employees with disabilities
Clinical Data Reviewer supporting Syneos Health’s life sciences and drug - development services. Reviewing clinical data and collaborating on solutions that accelerate patient progress.
Clinical Data Reviewer evaluating oncology clinical trial data for Syneos Health, a life sciences services organization. Collaborating with Clinical Solutions teams to accelerate drug development and commercialization.
Clinical Data Reviewer evaluating oncology clinical trial data for Syneos Health, a life sciences services organization. Supporting drug development solutions for pharmaceutical and healthcare customers.