• Responsible for management/oversight of study and regional/country level activities from study startup through conduct and study close • May manage the study start up process in countries assigned • Oversees pCRO responsible for these activities as applicable • Provides country level input on Startup and Recruitment milestones • Collaborates with accountable roles to identify and manage deviations and risks in study startup and execution • Ensures compliance to relevant Global and Local, internal and external requirements and regulations • Timely communication between the global and local study teams • Supports the Country/investigator outreach process, site identification and feasibility • Acts as the study level point of contact for all study-level questions for the Local Study Team • Identifies country level trends to improve deliverables processes • Ensures audit/Inspection readiness during start-up and conduct

Role Description Client in the pharmaceutical industry is seeking a GenAI Operations / Technical Lead to lead the design, deployment, and operational support of enterprise-scale Generative AI solutions. This is a hands-on technical leadership role focused on building scalable, production-ready GenAI applications that improve business efficiency across the organization. The ideal candidate has deep experience deploying GenAI applications in enterprise environments, with expertise in agentic AI, cloud platforms, and GenAI operations, including monitoring, testing, and production support. - Lead the architecture, deployment, and operational support of enterprise GenAI applications. - Build and maintain AI solutions leveraging the latest LLM and agentic AI capabilities. - Design agentic workflows using LangGraph and/or LangChain. - Establish best practices for GenAI operations, including monitoring, testing, evaluation, and observability. - Integrate structured and unstructured data from platforms such as SharePoint, Databricks, and Snowflake. - Ensure AI solutions are scalable, reliable, and production ready. - Provide hands-on technical leadership across multiple AI initiatives. Qualifications - Experience leading the technical delivery of enterprise GenAI applications. - Strong hands-on experience with production LLM applications. - AWS expertise is required; experience with Azure is preferred, and GCP is a plus. - Experience with LangGraph and/or LangChain. - Experience with GenAI monitoring, testing, evaluation, and production support. - Experience working with structured and unstructured enterprise data. - Strong Python and software engineering skills. - Experience in large enterprise environments. Requirements - Experience with RAG architectures and vector databases. - Familiarity with MLOps, CI/CD, and containerized deployments. - Multi-cloud experience across AWS, Azure, and GCP.

Role Description The IT Operations Analyst applies in-depth knowledge to independently manage the OhioRISE IT (Information Technology) Service Management desk, ensuring timely resolution and high satisfaction rates from external/internal stakeholders, as well as state regulatory bodies. This person handles incident management, direct issue resolution, and data analysis. The IT Operations Analyst also collaborates with technical teams to transform IT Service Management using high levels of automation. - Investigates and resolves complex technical issues, providing support and guidance to team members. - Analyzes complex system performance data to identify potential bottlenecks or performance issues. - Coordinates responses to IT incidents, ensuring timely resolution and minimal impact on business operations. - Identifies opportunities to optimize IT processes and areas for improvement. - Conducts routine risk assessments, developing strategies to mitigate potential risks. - Communicates with different stakeholders to plan, test, and implement changes to IT systems. - Completes reports for management, maintaining accurate and up-to-date documentation of systems, processes, and procedures. - Ensures adherence to security policies by conducting risk assessments and monitoring compliance with regulatory requirements. - Assists with capacity planning and resource allocation. - Performs other duties as assigned. Qualifications - 1-3 years of experience working in relational databases. - Willingness to travel up to 5% of the time, specifically within New Albany, Ohio. Requirements - Resides in Ohio. - Strong problem solving, problem tracking, and organizational skills. - Previous experience with ETL (Extract, Transform, and Load) and workflow automation tools. - ITIL (Information Technology Infrastructure Library) 4 Foundation Certification or equivalent experience. - Ability to work successfully in an independent, self-driven setting. - Excellent communication skills, both written and verbal. - Strong attention to detail. Education - Bachelor's degree and/or specialized training, or equivalent work experience (high school diploma or GED + 4 years of relevant experience). Benefits - Comprehensive medical, dental, and vision coverage. - Paid time off. - Retirement savings options. - Wellness programs and other resources, based on eligibility.

Role Description The Manager, Clinical Operations is a seasoned professional with wide-ranging experience and a thorough understanding of clinical study management, biospecimen acquisition, FDA and ICH regulations, and Good Clinical Practices (GCP). The candidate must be self-motivated, able to work and lead in a remote team environment, and establish strong, positive relationships with both internal departments, external clinical study sites, and biospecimen vendors. The successful candidate contributes to the development of Clinical Affairs processes and procedures at the project and company levels pertaining to Clinical Operations involvement in our clinical studies. The Manager, Clinical Operations will provide leadership and career development, mentoring, and training for CRA, biorepository, and clinical trial logistics staff as well as be responsible for Clinical Operations staff resourcing. Key Duties - Manage and facilitate the personal development of CRAs, including fostering career growth and providing relevant company-specific, ethical, and regulatory trainings. - Serve as a mentor and guide to junior employees, overseeing the personal development of clinical trial logistics and biorepository personnel. - Partner with the Clinical Affairs Director to create and implement the strategic vision for the Clinical Operations team. - Lead Clinical Operations level initiatives for the development, maintenance, and implementation of processes, tools, templates, and plans. - Regularly monitor the overall health of the clinical studies from initiation to closure, including evaluation of key metrics (enrollment, site activation) and escalation of project risks. - Lead and prepare content for internal meetings with leadership, internal cross-functional teams, and external collaborators. - Function as a working manager and take on CRA responsibilities as needed. - Oversee CRAs during site visits (site initiation visit, interim monitoring visits, and close-out visits) as needed. - Oversee clinical operations aspects of timely data monitoring and partner with Clinical Affairs team leaders and study sites regarding query generation and reconciliation. - Direct the creation and collection of required study documents both internally and with investigational study sites. - Responsible for all aspects of the biospecimen acquisition program, including forecasting and managing resources, timelines, and budgets. - Implement strategies and best practices for the Clinical Operations team to build and maintain relationships with investigational study sites and vendors. - Responsible for resource allocation for the Clinical Operations team for assigned projects. - Other duties as assigned. Qualifications - B.S. in Biological/Health Sciences or related Scientific fields; master’s degree preferred. - Certificate of completion from a Clinical Research Associate program is preferred. - Minimum of 5 years of experience mentoring, managing, and leading a team. - Minimum of 5 years experience as a CRA and/or Lead CRA. - Minimum of 1-2 years experience with managing and/or working in clinical trial logistics and/or biorepository operations. - Experience with internal sample collection is preferred. - Basic knowledge in microbiology, immunology, or molecular biology and biochemistry as related to infectious diseases. - Thorough knowledge of FDA, ICH, and GCP guidelines. - Strong knowledge and experience with TMF/eTMF, EDC systems, and CTMS preferred. - Be an initiative-taker, detail-oriented, organized, and able to prioritize and balance workloads to meet strict deadlines. - Highly motivated, readily adapts to changing priorities. - Excellent organizational skills with high attention to detail. - Able to work successfully under tight timelines. - Ability to manage, prioritize, and routinely report progress on multiple projects to cross-functional teams and Clinical Management. - Ability to read, understand, and follow all company SOPs and guidelines and ensure compliance in direct reports.