Ensure data readiness for important milestones
Review participant level data across a study in adherence with CRF Completion guidelines and the Data Review Plan
Conduct point-to-point data checks and interpretive analysis
Generate queries on discrepant data and follow to resolution
Create and use data review best practices and associated data review tools
May identify protocol deviations during routine clinical review and escalation as appropriate
Follow relevant SOPs and regulations
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
Background in clinical monitoring or RN strongly preferred
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
Basic understanding of how data points from different fields/CRFs interact
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
Possess basic knowledge of data management
Good written and oral communication skills with strong attention to detail required

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

Clinical Data Reviewer – Internal Medicine

Key skills