Clinical Data Reviewer – Internal Medicine

📋 Description

• Ensure data preparedness for key milestones

• Review participant-level data throughout a study in accordance with CRF Completion guidelines and the Data Review Plan

• Perform point-to-point data verifications and interpretive analysis

• Create queries on inconsistent data and pursue resolutions

• Develop and implement best practices for data review and related tools

• May identify protocol deviations during routine clinical evaluations and escalate as necessary

• Adhere to relevant SOPs and regulatory requirements

• Collaborate with data management, clinical and site management, along with other study team members

• Participate in Clinical Meetings and Study Meetings as required

⛳️ Requirements

• Bachelor’s degree or a nursing degree is preferred

• A minimum of 7 years of clinical research experience within the pharmaceutical sector

• Experience in clinical monitoring or as a Registered Nurse is strongly preferred

• Required experience in direct clinical review and query writing/resolution

• Must possess adequate clinical knowledge to evaluate if participant data is scientifically and clinically valid

• Previous experience with Electronic Data Capture (EDC) systems preferred

• Skilled in reviewing large-scale listings in Microsoft Excel format

• Basic understanding of the interaction between data points from various fields/CRFs

• Capability to work autonomously in a virtual environment as well as within a remote team

• Ability to prioritize and adapt work tasks promptly as needed

• Basic knowledge of data management practices

• Excellent written and verbal communication skills with a strong attention to detail are essential

🏝️ Benefits

• Health benefits including Medical, Dental, and Vision coverage

• Company-matched 401k plan

• Eligibility to participate in the Employee Stock Purchase Plan

• Opportunity to earn commissions/bonuses based on both company and individual performance

• Flexible paid time off (PTO) and sick leave