About the role

Clinical Data Reviewer specializing in Oncology at Syneos Health. Ensuring data readiness and conducting clinical reviews for oncology studies.

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

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
Possess sufficient clinical knowledge to assess if participant data is scientifically and clinically valid.
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

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