• Support the design, start-up, and execution of global clinical trials, ensuring adherence to protocol, regulatory requirements, and data integrity standards. • Contribute to development of clinical protocols, statistical analysis plans, investigator brochures, and regulatory documents, with focus on study endpoints, key efficacy outcomes, and safety assessments. • Collaborate with cross-functional teams to support endpoint strategy, event adjudication processes, and safety monitoring. • Participate in development and oversight of endpoint adjudication charters, safety monitoring plans, and Data Monitoring Committee (DMC) interactions. • Provide clinical input into data management plans, CRF design, and clinical data review, with focus on key study endpoints, efficacy and safety outcomes, and/or imaging or biomarker endpoints, as applicable. • Conduct ongoing clinical data review and signal detection, supporting identification and resolution of safety and data quality issues across global trial sites. • Support preparation and interpretation of interim analyses, database lock activities, and top-line data readouts. • Assist Development Lead and Clinical Scientist Director with medical monitoring activities and oversight of CROs, vendors, and adjudication committees. • Collaborate with clinical operations, biostatistics, safety, regulatory, and medical affairs teams to ensure successful delivery of clinical studies across relevant indications and endpoint strategies. • Contribute to clinical study reports, regulatory submissions, scientific publications, and presentations for internal and external stakeholders. • Identify operational or scientific risks and proactively implement mitigation strategies across cross-functional teams.

• Support late-phase clinical development by translating scientific and clinical strategy into actionable execution across clinical trials • Provide hands-on oversight of protocol execution, medical data review, and clinical data quality • Ensure clinical trials are executed in alignment with protocol intent, regulatory expectations, and Amgen quality standards • Serve as a clinical and scientific subject-matter expert for the assigned therapeutic area and disease indication, with a strong focus on protocol execution and data integrity • Contribute to medical monitoring activities and support ongoing assessment of subject-level clinical data to identify trends, risks, and emerging issues • Present information internally and externally, anticipating and actively managing problems across a broad spectrum of cross-functional teams • Provide guidance and assistance in the identification and management of collaborators, consultants, and/or Clinical Research Organizations (CROs) • Work cross functionally to ensure clinical strategy is translated into the development of the study concept document, study protocol, and related documents • Review and analyze clinical trial data to ensure accuracy, completeness, and adherence to protocol and regulatory requirements • Conduct thorough data quality assessments in the context of a data monitoring plan to maintain high standards of data accuracy and integrity throughout the trial lifecycle

• Full accountability for country-level study delivery and performance • Serve as the client’s voice within Civia, ensuring their priorities, timelines, and standards are understood and met across all functions • Maintain disciplined oversight of start-up, recruitment, regulatory progress, data quality, and site performance • Drive immediate cross-functional action when performance deviates from plan • Lead structured governance routines with clarity, transparency, and solution orientation • Ensure ongoing audit and inspection readiness across all study activities

Role Description As a member of the Clinical Services team, the Utilization Management Inpatient (UM IP) Clinical Specialist receives, researches, and takes action related to documentation and requests from various sources related to Inpatient Utilization Management cases. The UM IP Clinical Specialist partners with licensed health professionals on appropriate actions and responses to support efficient and effective clinical reviews. - Utilize clinical knowledge and critical thinking to research and review IP UM requests. - Communicate effectively with internal and external stakeholders, including providers and team members. - Exhibit excellent time management skills to ensure timeliness of UM activities. - Organize and maintain reference documents, policies, and procedures. - Perform detailed research and problem-solve using sound decision-making skills. - Initiate referrals to adjacent teams as needed. - Discuss discharge planning with providers as needed. Qualifications - High school diploma or equivalent. - Clinical experience is required. - At least 2 years of clinical experience preferred. - CMA or CNA preferred. - Strong communication skills, both oral and written. - Computer skills, including Microsoft Office, Outlook, and internet search. - Knowledge of medical terminology, anatomy, and coding (CPT, DX, HCPCs). Requirements - Ability to work independently with a high volume case load. - Prioritize tasks, meet deadlines, and achieve operational standards. - Maintain confidentiality and focus on meeting customer needs. - Adapt to changes in the healthcare insurance industry. - Utilize strong organization, data entry, and administrative skills. Benefits - Medical, dental, and vision coverage for employees and their eligible family members, including mental health benefits. - Annual employer contribution to a health savings account. - Generous paid time off varying by role and tenure in addition to 10 company-paid holidays. - Market-leading retirement plan including a company match on employee 401(k) contributions. - Up to 12 weeks of paid parental time off (eligibility requires 12 months of continuous service). - Award-winning wellness programs that reward participation. - Employee Assistance Fund for those in need. - Commute and parking benefits.