Sobre este puesto de Data Reviewer Specialist en Kcasbio

Kcasbio · Híbrido · Kansas City

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

(Please note this is a representative summary of responsibilities, not a comprehensive or exclusive list of the duties to be performed in any position. Employees must follow instructions and perform additional duties as requested.)

WHO YOU ARE

You will thrive at KCAS Bio if you enjoy a relational environment, are purpose- and values-driven, embrace constant development and supportive leadership, and enjoy being part of innovative work.

WHAT YOU’LL GET

Our benefits include, and extend beyond, the traditional package. At KCAS Bio, you will enjoy company sponsored events like food trucks, family days and spirit days. You will grow in your career with KCAS University. You will be able to connect with like-minded employees to further KCAS Bio's approach to key areas such as wellness, inclusion, and community outreach. You will engage as an owner in our stock ownership program. You will have access to the latest technology. And you will be able to invest in the community with paid time off to volunteer.

Learn more about the Benefits at KCAS Bio

WHO WE ARE

We are a fast-growing contract research organization (CRO) headquartered in Kansas City, pioneering the latest drug development in both human and animal health fields. Demand for our expertise is growing and so is our need for great people to work in nimble, empowered teams committed to one another’s growth. At KCAS Bio, we advance both great science AND great people.

Learn more about what it is like to work at KCAS Bio

KCAS Bio is proud to be an Equal Opportunity Employer. Among other things, we provide equal employment opportunities without regard to race, color, religion, national origin, ancestry, marital status, veteran status, age, disability, pregnancy, genetic information, sex, sexual orientation, gender identity, or any other legally protected category; we recruit qualified candidates without regard to citizenship status based on internal processes that enable us to hire the right candidates consistent with the appropriate U.S. Immigration framework; and (3) we work with and provide reasonable accommodations to individuals with disabilities and for sincerely held religious beliefs, observances, and practices. Anyone who needs reasonable accommodation may send an email to [email protected] or call 913-248-3000 (for TTY assistance call 711) and ask for Human Resources.

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Sobre este puesto de Data Reviewer Specialist en Kcasbio

In this role, we will rely on you to:

To qualify specifically for this role, you will have:

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