Data Reviewer Specialist

Performing critical work that impacts our industry and our world’s health while problem solving and innovating in the field – that is what we get to do every day at KCAS Bio. If that gets you excited too, then maybe working at KCAS Bio is for you.

When you work as a Data Reviewer Specialist at KCAS, you get to further our mission by serving as a contributing specialist for studies, independently carrying out data review activities from study execution through report finalization. You will utilize your strong knowledge of regulatory policies and data review requirements to assess scientific data and reporting, support timely audit responses, and ensure the accuracy and integrity of study deliverables.

As a Data Reviewer Specialist, you will work closely with scientific teams and other departments across KCAS, serving as a trusted resource for complex data review activities while maintaining a high level of professional interaction both within and outside of the department.

In this role, we will rely on you to

• Act as a data reviewer for assigned studies, performing comprehensive review and verification of scientific data with minimal guidance
• Be responsible for final data review and sign-off, including 100% review of Excel spreadsheets, report tables, and manipulated data transmittals
• Verify outliers, repeated samples, positive predose results, placebo results, and other data requiring additional review or investigation
• Review reports and supporting documentation for accuracy, completeness, consistency, and compliance with applicable requirements
• Support study activities from data review through report finalization, ensuring data-related issues are identified and resolved in a timely manner
• Assist with expediting responses to Quality Assurance audits and other data-related questions or findings
• Apply a thorough understanding of regulatory policy and compliance requirements when reviewing scientific data and reports
• Utilize laboratory software, including Analyst and Watson, to perform data review activities
• Make minor changes within LIMS software as needed to support accurate study data and reporting
• Identify data discrepancies or inconsistencies and work collaboratively with scientific and cross-functional teams to resolve issues
• Generate and update SOPs, policies, and other applicable departmental documentation as required
• Maintain familiarity with current industry trends, regulatory expectations, and data review practices
• Provide procedural training and coaching to team members and serve as a technical resource for data review activities
• Act in a leadership capacity and mentor less experienced Data Review team members as needed
• Archive study data and associated documentation as required
• Maintain a high level of professional communication and collaboration with both intra- and interdepartmental partners
• Manage multiple study priorities while maintaining accuracy and supporting established study and reporting timelines
• Perform all aspects of the job in a way that supports company brand and supports company mission, vision, and values
• Perform other job duties as assigned

To qualify specifically for this role, you will have

• Bachelor’s degree in a scientific field
• At least 4 years of related experience gained from research or industry
• Expert knowledge of data generated by the laboratory
• Thorough understanding of regulatory policy and compliance requirements
• Familiarity with current industry trends and regulatory expectations
• Experience performing scientific or bioanalytical data review, including the ability to independently review and sign off on data with minimal guidance
• Experience performing detailed verification of spreadsheets, report tables, manipulated data transmittals, outliers, repeated samples, and other study data
• Proficiency with applicable laboratory software used for data review, including Analyst and Watson
• Familiarity with LIMS or similar laboratory information management systems
• Strong attention to detail and commitment to data integrity and quality
• Strong technical writing skills and basic computer skills
• Good written and verbal communication skills
• Willingness and ability to provide procedural training and coaching
• Ability to act in a leadership capacity and mentor others
• Strong organizational and problem-solving skills with the ability to manage multiple studies, priorities, and deadlines independently
• Ability to collaborate effectively with scientific, Quality Assurance, and other cross-functional teams