• 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

• Functions in a clinical review capacity to evaluate all cases, which do not pass the authorization approval process at first call while promoting a supportive team approach with call center staff. • Clinical reviewers are supported by Field Medical Directors (MDs) in the utilization management determination process. • Reviews charts and analyzes clinical record documentation in order to approve services that meet clinical review criteria. • Conducts ongoing activities which monitor established quality of care standards in the participating provider network and for other clinical staff. • Converses with medical office staff to obtain additional pertinent clinical history/information; notifies of approvals and denials, giving clinical rationale, while providing optimum customer service through professional/accurate communication and maintaining NCQA and health plans required timeframes. • Documents all communication with medical office staff and/or treating provider. • Practices and maintains the principles of utilization management by adhering to policies and procedures. • Participates in on-going training programs to ensure quality performance in compliance with applicable standards and regulations, as well as, being audited to ensure guidelines are applied appropriately.

Title: Clinical Reviewer - PASRR (2026-49948) Location: United States Job Description: Job Number: 2026-49948 Category: Healthcare Shift: Day Exempt/Non-Exempt: Exempt Business Unit: ForHealth Consulting Department: ForHealth Consulting - Community Service - W401950 Job Type: Full-Time Num. Openings: 2 Work Location: 100% Remote Salary Minimum: USD $60,000.00/Yr. Salary Maximum: USD $78,000.00/Yr. Job Summary Under the general supervision of the Associate Director, or designee, the Clinical Reviewer - PASRR is responsible for reviewing submitted referrals and any accompanying clinical documentation to the Pre-Admission Screening and Resident Review (PASRR) unit for completeness. The Clinical Reviewer- PASRR may also complete Abbreviated Level II evaluations in accordance with relevant guidelines and regulations. This position facilitates individuals with suspected serious mental illness (SMI), seeking admission to or currently residing in a nursing facility, receive an in person or abbreviated evaluation and nursing facility placement determination. Major Responsibilities - Participate as an active member of a multi/inter-disciplinary team to evaluate and determine the appropriateness of nursing facility placement for individuals with suspected SMI. - Complete thorough review of all referrals and accompanying clinical documentation for completeness and determines if the referral can be moved to an abbreviated or full PASRR Level II evaluation. - Demonstrate an ability to use critical thinking skills to identify when to conduct additional outreach or review on assigned cases and when to escalate to assigned supervisor. - Complete Abbreviated Level II evaluations on an individualized basis, but in accordance with the most current federal rules, regulations, and evaluative criteria and required timeframes. - Review and document all relevant information into data system applications in accordance with program guidelines and regulations. - May participate in the preparation of appeals for determinations made through the PASRR process. - Prepare and respond to requests for statistics and resource/service data. - Foster and promote continuity of care and cooperative partnerships by liaising with health care providers, acute care hospitals and other programs/organizations involved in the provision of services. - Maintain positive working relationships with individuals served, and relevant informal supports, provider organizations, and state agencies. - Maintain the confidentiality of all business documents and correspondence per UMass Chan Medical School/ForHealth Consulting procedures and HIPAA regulations. - Participate in performance improvement initiatives and demonstrates the use of quality improvement in daily operations. - Participate in training and mentoring of new clinical reviewer staff. - Comply with established departmental policies, procedures and objectives. - Comply with all health, safety and program regulations and requirements. - May participate in public relations efforts, attending conferences and meetings as needed. - Perform other similar and related duties as required or as directed. Required Qualifications - RN, LPN or social worker licensed to practice in Massachusetts with an appropriate degree - 3-5 years work experience with at least 3 recent years providing direct service or case management - Expertise in working with individuals with mental health behavioral health issues. - Ability to understand and utilize resources for problem solving, in order to deal with problems involving multiple variables, effectively prioritizing and executing tasks in a high pressure, fast paced environment. - Ability to work weekends Preferred Qualifications - Extensive experience with program related services/populations preferred Supervision Supervision Received Will be supervised by clinical coordinator. Supervision Exercised This position does not include supervisory responsibilities. Environmental Working Conditions Remote position which requires working at computer for all tasks. Posting Disclaimer: This job posting outlines the primary responsibilities and qualifications for the role but is not intended to be an exhaustive list. Duties and expectations may evolve in response to the needs of the department and the broader institution. In alignment with our commitment to pay transparency, the base salary range for this position is listed above (exclusive of benefits and retirement). At UMass Chan Medical School, final base salary offers are determined based on a combination of factors, including your skills, education, and relevant experience. We also consider internal equity to ensure fair and consistent compensation across our teams. Please note that the range provided reflects the full base salary range for this position. Offers are typically made within the midrange to allow for future growth and development within the role. In addition to base pay, UMass Chan offers a comprehensive Total Rewards package, which includes paid time off, medical, dental, and vision coverage, and participation in a 401(a)-retirement plan, with the option to contribute to a voluntary 403(b) plan.

Role Description This is a fully remote role supporting our GMP Laboratory in Middleton, WI. We welcome applicants from all locations within the US. - Must be legally authorized to work in the United States without sponsorship. - Must be able to pass a comprehensive background check, which includes a drug screening. The Data Reviewer performs review of a variety of routine and complex analytical analysis experiments that are conducted on pharmaceutical and biopharmaceutical compounds with various formulations and/or biological matrices. Ensures analyses are following validated or experimental analytical procedures, and compare results to methodology, protocol and product specifications, Standard Operating Procedures (SOPs) acceptance criteria, and Good Manufacturing Practices (GMP). Reviews data entered into databases and reports and monitors the quality of the laboratory data. Possesses a thorough understanding of laboratory procedures and can reliably conduct complex analysis review independently. A Day in the Life: - Evaluates laboratory data for compliance with analytical methods, client directives, and SOPs. - Reviews sample results for scientific soundness, completeness, accurate representation of the data, and final reported results. - Communicates with laboratory staff to proactively maintain the quality of laboratory documentation. - Delivers review findings noting deficiencies within the analytical data or reports in a clear and concise manner. - Escalate significant deficiencies to the project leader or supervisor for assessment. - Facilitates in conversations with lab staff on best documentation practices and addressing quality findings. - Advocates for quality and review process changes. - Identifies and supports process improvement initiatives. - Performs other duties as assigned. Qualifications - Bachelor's degree or equivalent and relevant formal academic/vocational qualification. - Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years). - In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. Requirements - Demonstrated knowledge of PCR and sequencing strongly preferred. - Previous experience with formal data review in GMP Lab strongly preferred. - Previous experience with method validation or method validation data review strongly preferred. - Previous experience with chromatographic review and Empower strongly preferred. - Thorough knowledge of SOPs and Federal Regulations to include GLP and GMP. - Thorough knowledge of chromatography may be required. - Strong technical knowledge including an understanding of laboratory procedures, methodology, and standards. - Strong verbal and written communication skills. - Strong attention to detail. - Ability to balance time and remain focused on work to meet goals. - Ability to train staff on basic review techniques. - Ability to independently review laboratory reports and analytical methods. - Ability to deal with multiple and changing priorities. - Ability to provide clear and concise feedback and/or documentation of results. - Ability to work in a collaborative team environment. - Ability to work efficiently in a remote capacity. Benefits - Thermo Fisher Scientific values the health and wellbeing of our employees. - We support and encourage individuals to create a healthy and balanced environment where they can thrive. Work Environment - Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner. - Able to work upright and stationary and/or standing for typical working hours. - Able to lift and move objects up to 25 pounds. - Able to work in non-traditional work environments. - Able to use and learn standard office equipment and technology with proficiency. - May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments. - Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.