Alimentiv

• Responsible for the clinical operations of a project within a defined regional/global level. • Provides oversight of project deliverables, assigned Clinical Research Associate (CRAs) and Investigator sites. • The COL acts as a primary liaison between the CRAs and the clinical project team. • Additional responsibilities include project specific training of CRAs, conducting assessment visits with CRAs. • Implementation of enrollment and recruitment strategies, preparation of the monitoring plan and other structural documentation. • Oversight of monitoring visit scheduling, site and monitoring performance metrics, issue escalation and corrective actions. • Develop study tools for site and CRA use, review visit reports, review and track protocol deviations. • Support other objectives for clinical operations and the clinical project team.

• Responsible for the day-to-day activities and delivery of Global Regulatory Affairs support services. • Role will include management of clinical trial applications to Competent Authorities, Ethics Committees and Regulatory Agencies. • Research, review and reporting on applicable global regulations and requirements. • Develop stakeholder tools, process/document regulatory risk assessments. • Provide support, expertise and represent the unit with other functional units, sponsors, researchers and/or regulatory authorities. • Ensure high quality, timely service delivery processes are maintained in accordance with corporate, industry and regulatory standards and guidelines. • May be required to coach peers and/or provide input for staff performance reviews.

• Responsible for the day-to-day activities and delivery of Global Regulatory Affairs support services. • Role will include management of clinical trial applications to Competent Authorities, Ethics Committees and Regulatory Agencies. • Develop stakeholder tools, process/document regulatory risk assessments, and provide support, expertise and represent the unit with other functional units, sponsors, researchers and/or regulatory authorities. • Ensure high quality, timely service delivery processes are maintained in accordance with corporate, industry and regulatory standards and guidelines. • May be required to coach peers and/or provide input for staff performance reviews.

• Drive and deliver on the Alimentiv Site Network (ASN) Strategy. • Manage the identification, outreach, recruitment and onboarding of high quality, high performing sites into the North America ASN. • Develop strong relationships with high priority sites & partners through virtual or face-to-face meetings and conference attendance (travel required). • Build a deep understanding of the challenges of clinical research for sites in GI and how these challenges impact recruitment and research operations. • Maintain and deliver accurate, real-time analytics on our ASN sites. • Drive site recruitment in new and existing therapeutic areas and geographies. • Build solutions to establish and grow a pipeline of high potential sites that are starting in, or naïve to, clinical research. • Develop a holistic site engagement and support model.

• Drive the project management, process optimization and growth of the ASN globally through identification, outreach, collaboration with and onboarding of clinical sites with a focus on enhancing clinical trial delivery. • Develop and drive Key Performance Indicators around the success of ASN. • Find innovative solutions to existing and emergent challenges of patient recruitment and facilitate enhanced service delivery to sites within the ASN. • Manage the identification, outreach, recruitment and onboarding of high quality, high performing sites. • Build strong relationships with high priority sites & partners through virtual or face-to-face meetings and conference attendance. • Maintain and deliver accurate, real-time analytics on ASN sites. • Develop processes and workflows to support a scalable and growing ASN platform.

• Design, build, and operationalize scalable data solutions to support enterprise analytics and AI/ML initiatives. • Architect end-to-end pipelines using industry-standard tools. • Drive automation and move solutions effectively into production. • Ensure compliance with data governance requirements (including GxP and HIPAA/GDPR). • Build reusable, integrated pipelines and analytical models that promote self-service analytics. • Provide technical leadership across the team and mentor junior engineers. • Partner with business stakeholders to align data engineering with organizational objectives.

• Assist in the execution of all Image Services activities ensuring focus on data integrity and reliability in accordance with standard processes, sponsor guidelines, industry best practices and regulatory standards. • Provide image collection services to stakeholders in areas of data collection and user system operations. • Contribute to the delivery of high-quality image services support to internal and external customers, clinical sites, and sponsors. • May require ability to work shifts, statutory holidays and provide on-call support from time to time.

• Manage, deliver and/or perform full clinical site monitoring services for one or more projects, which may include multiple services, be complex in nature and/or run on a multinational scale. • In-house based position, responsible for the design and oversight of project monitoring services including training, site/patient recruitment, site data/document management, monitoring project site budgets and regulatory filings that aligns with SOPs, study guidelines and GCP best practices. • In the function of Lead CRA, will act as primary liaison between CRAs and project team and may be required to participate in the development of project plans, protocols, CRFs, communications or other monitoring forms, documents and tools. • Represents the corporation by maintaining collaborative relationships with stakeholders.

• Manage, deliver and/or perform full clinical site monitoring services for one or more projects, which may include multiple services, be complex in nature and/or run on a multinational scale. • In-house based position, responsible for the design and oversight of project monitoring services including training, site/patient recruitment, site data/document management, monitoring project site budgets and regulatory filings that aligns with SOPs, study guidelines and GCP best practices. • In the function of Lead CRA, will act as primary liaison between CRAs and project team and may be required to participate in the development of project plans, protocols, CRFs, communications or other monitoring forms, documents and tools. • Represents the corporation by maintaining collaborative relationships with stakeholders.

• Conduct proactive, multi-channel outreach via phone, email, and video to identify, qualify, and convert prospects into revenue-generating engagements with pharma, biotech, and academic clinical trial sponsors. • Manage the full inside sales cycle independently, from coordinating discovery calls and capability presentations through proposal development, pricing using pre-approved frameworks, and opportunity closing. • Design, build, and execute targeted lead generation campaigns using email marketing sequences, LinkedIn outreach, and nurturing workflows to grow qualified lead volume. • Plan, coordinate, and execute AcelaBio’s trade show and conference participation end to end, including booth logistics, pre-event promotional campaigns, on-site lead capture, and structured post-event follow-up sequences.