Clinical Data Reviewer - Oncology
About The Position
Syneos Health is a leading life sciences services organization that partners with innovators across the drug development and commercialization continuum. The Clinical Solutions team members act with a drug development mindset, applying their expertise to understand customer needs and shape solutions. Whether in a Functional Service Provider partnership or a Full-Service environment, team members collaborate with problem solvers to help customers achieve their goals. The company is agile and driven to deliver for its colleagues, customers, and patients. Syneos Health focuses on developing its people through career development, progression, supportive management, training, and recognition. They are committed to building an inclusive culture where individuals can be authentic, driven by a purpose to shape solutions that impact lives. They continuously build a company that is desirable to work for and work with, believing that diverse colleagues can shape the future of healthcare and patient progress.
Requirements
- Industry experience with Oncology is required
- Candidates must reside in US, UK, or Canada with no sponsorship needs.
- At least 7 years of clinical research experience in the pharmaceutical industry
- Direct clinical review and query writing/resolution experience required
- Possess sufficient clinical knowledge to assess if participant data is scientifically and clinically valid.
- 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
Nice To Haves
- Strong monitoring experience is a plus
- Prior EDC experience preferred
Responsibilities
- 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 Meetings, as necessary
Benefits
- company car or car allowance
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Associate degree
