Emerald Clinical

• Provide line management and leadership to the global start-up team, including coaching, development, and performance management • Define and implement the overall start-up strategy, ensuring alignment with global objectives and regional needs • Oversee end-to-end study start-up activities, including country/site feasibility, submissions, ethic approvals, and activation timelines • Drive process optimisation and best practices to increase efficiency, consistency, and quality across all start-up deliverables • Collaborate with Business Development and Proposals teams to support bid defenses, feasibility input, and strategic study planning • Act as a key stakeholder in client engagement, ensuring start-up expectations are clearly defined and met • Monitor and report on start-up KPIs, timelines, and risks, implementing mitigation strategies as needed • Partner cross-functionally with Clinical Operations, Regulatory Affairs, Project Management, and external vendors • Support business growth initiatives by ensuring scalable and high-performing start-up operations • Ensure compliance with ICH-GCP, regulatory requirements, and company SOPs • Champion a culture of continuous improvement, collaboration, and accountability

• Coordinate the identification, feasibility assessment, and selection of investigators and sites to undertake the trial. • Complete all monitoring activities per the Monitoring Plan along with completing monitoring visit reports, accurately and within the predetermined timeframe. • Prepare, plan, organize, and conduct site evaluation visits and report on these visits to assist in site selection. • Prepare, submit, and/or liaise with regulatory specialist colleagues, regarding the preparation of regulatory packages, importation/exportation requirements, and updates of Ethics Committee packages. • Negotiate site budgets, coordinate for site contract execution, track invoicing, and ensure timely site payments. • Prepare, plan, organize, and conduct site initiation visits. • Develop and maintain appropriate monitoring tools and project-specific documents. • Motivate and train investigators to ensure that the trial site personnel have a good understanding of the protocol, investigational product, and requirements of the trial so they can fulfill their obligations to conduct the trial accurately and to deadlines. • Collect, review, and approve essential documents from trial sites, to ensure quality and compliance, and code documents for Trial Master File (TMF) filing. • Reconcile contents of in-house TMF and site’s Investigator Site Files. • Coordinate distribution, tracking, handling, and destruction of investigational product and other trial supplies per site/trial requirements. • Maintain trial information using the clinical trial management system and any other tracking and reporting tools for the trial. • Support strategies to boost recruitment efforts.

• Support the implementation and ongoing maintenance of PMO standards, methodologies, and tools across clinical and operational projects • Develop and maintain project dashboards, KPIs, and performance metrics to provide actionable insights • Assist study teams with project timeline tracking and updates • Prepare status reports, presentations, and governance materials for senior leadership and stakeholders • Facilitate project governance processes, including stage gates, audits, and reporting cycles • Collaborate with Project Managers to improve adherence to SOPs, regulatory requirements, and best practices • Analyse project data to identify trends, risks, and opportunities for improvement • Support change management initiatives and continuous improvement efforts across the PMO • Assist in preparing and facilitating Project Management Forum meetings • Contribute to the development and enhancement of tools and processes to support high-quality project documentation • Support project resourcing activities, including coordination for holiday cover

• Lead contract and budget development across multiple studies • Serve as the main point of contact for sites regarding all contract and budget matters • Oversee site contract negotiations and ensure alignment with sponsor expectations • Partner with clinical operations and project teams to manage timelines, deliverables, and change requests • Coordinate project-specific vendor activities and site payment processes • Track and forecast project budgets, scope changes, and key milestones • Contribute to internal process improvements and support training activities • Ensure compliance with ICH-GCP, SOPs, and all relevant regulatory guidelines

• Provide strong, independent leadership for assigned clinical projects, ensuring successful execution. • Serve as the primary point of contact for clients, vendors, and internal stakeholders. • Oversee study management activities, including site selection, initiation, monitoring, and closeout. • Develop and maintain study timelines, budgets, and project plans, ensuring adherence to scope. • Mitigate risks and proactively address challenges to keep projects on track. • Ensure compliance with ICH-GCP, regulatory guidelines, and company SOPs. • Manage vendor relationships and study-specific contracts. • Provide mentorship and guidance to junior project team members. • Support proposal development, bid defense meetings, and business growth initiatives. • Participate in internal and external project team meetings to ensure alignment and success.

• Onboarding: Onboarding to ensure smooth integration of new hires. • Employee Relations: Serve as the primary point of contact for employee relations, addressing grievances, resolving conflicts, and guiding managers through disciplinary actions. • Compliance & Risk Management: Ensure strict compliance with all federal, state, and local employment laws and regulations. • Compensation & Benefits: Manage payroll, benefits administration, and annual compensation reviews. • Performance & Talent Management: Administer performance review processes, support goal-setting, and assist department leaders with succession planning and performance improvement plan. • HR Strategy & Analytics: Track HR metrics, utilize HRIS software.

• Coordinate the identification, feasibility assessment, and selection of investigators and sites to undertake the trial. • Complete all monitoring activities per the Monitoring Plan along with completing monitoring visit reports, accurately and within the predetermined timeframe. • Prepare, plan, organize, and conduct site evaluation visits and report on these visits to assist in site selection. • Prepare, submit, and/or liaise with regulatory specialist colleagues, regarding the preparation of regulatory packages, importation/exportation requirements, and updates of Ethics Committee packages. • Negotiate site budgets, coordinate for site contract execution, track invoicing, and ensure timely site payments. • Prepare, plan, organize, and conduct site initiation visits. • Develop and maintain appropriate monitoring tools and project-specific documents. • Motivate and train investigators to ensure that the trial site personnel have a good understanding of the protocol, investigational product, and requirements of the trial so they can fulfill their obligations to conduct the trial accurately and to deadlines. • Collect, review, and approve essential documents from trial sites, to ensure quality and compliance, and code documents for Trial Master File (TMF) filing. • Reconcile contents of in-house TMF and site’s Investigator Site Files. • Coordinate distribution, tracking, handling, and destruction of investigational product and other trial supplies per site/trial requirements. • Maintain trial information using the clinical trial management system and any other tracking and reporting tools for the trial. • Support strategies to boost recruitment efforts.

• Own the Early Phase strategic assessment of new business opportunities from RFP receipt through award. • Partner with Proposal Management to triage Early Phase opportunities and provide bid/no-bid recommendations. • Develop comprehensive Early Phase study strategies, including: Country and site selection approach, Investigator/site engagement strategy, Patient recruitment considerations, Study timelines and operational assumptions, Resource model and delivery approach, Identification and mitigation of operational risks. • Engage with Early Phase sites, investigators, and internal experts to validate feasibility and strengthen proposals. • Provide strategic recommendations to the VP Early Phase, Business Development, and leadership teams. • Lead the Early Phase operational strategy component of RFP responses. • Partner with Proposal teams to develop high-quality client proposals. • Review proposal budgets, timelines, assumptions, and delivery models to ensure alignment with strategy. • Provide input into pricing strategy and commercial positioning. • Support preparation and delivery of bid defence meetings and client presentations. • Act as an Early Phase SME in client meetings and strategic discussions. • Support sponsor conversations relating to study design, operational feasibility, recruitment strategy, and delivery approach. • Build strong relationships with investigators, Early Phase sites, and industry partners. • Represent Emerald at conferences, industry events, and client engagements as required. • Build and maintain Early Phase strategy tools and resources, including: Early Phase databases, Site and investigator intelligence, Capability materials, Proposal content libraries, Market intelligence. • Partner with Business Development and Marketing to strengthen Emerald’s Early Phase positioning. • Identify opportunities to improve processes, tools, and ways of working. • Establish scalable Early Phase strategy processes and governance. • Mentor and develop future Early Phase Strategy team members as the function grows. • Support the evolution of Emerald’s Early Phase strategy capability.

• Provide strong, independent leadership for assigned clinical projects, ensuring successful execution. • Serve as the primary point of contact for clients, vendors, and internal stakeholders. • Oversee study management activities, including site selection, initiation, monitoring, and closeout. • Develop and maintain study timelines, budgets, and project plans, ensuring adherence to scope. • Mitigate risks and proactively address challenges to keep projects on track. • Ensure compliance with ICH-GCP, regulatory guidelines, and company SOPs. • Manage vendor relationships and study-specific contracts. • Provide mentorship and guidance to junior project team members. • Support proposal development, bid defense meetings, and business growth initiatives. • Participate in internal and external project team meetings to ensure alignment and success.

• Provide strong, independent leadership for assigned clinical projects, ensuring successful execution. • Serve as the primary point of contact for clients, vendors, and internal stakeholders. • Oversee study management activities, including site selection, initiation, monitoring, and closeout. • Develop and maintain study timelines, budgets, and project plans, ensuring adherence to scope. • Mitigate risks and proactively address challenges to keep projects on track. • Ensure compliance with ICH-GCP, regulatory guidelines, and company SOPs. • Manage vendor relationships and study-specific contracts. • Provide mentorship and guidance to junior project team members. • Support proposal development, bid defense meetings, and business growth initiatives. • Participate in internal and external project team meetings to ensure alignment and success.