Emerald Clinical

Manager

• 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

Manager, Study Start Up

General

• 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

Site Contracts Lead, Mandarin Speaking

Clinical Operations

• 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.

Clinical Project Manager – Renal

Human Resources

• 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.

HR Manager

Research Analyst

• 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.

Clinical Research Associate 2

• 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, organise, and conduct site evaluation visits and report on these visits to assist with 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, organise, 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.
• Manage trial sites utilising both on-site and off-site activities including:
• - Verification of quality, accuracy, completion, and timeliness of data.
• - Ensure complete and efficient resolution of data queries, audits, issues, and liaise with Data Management and/or Quality colleagues, as needed.
• - Adhere to the trial protocol, all applicable project-related plans, as required by the project training matrix, and other relevant project-specific requirements.
• - Adhere to ICH/GCP and other regulatory guidelines and requirements as relevant to this trial including reporting of subject safety - adverse/serious adverse events, protocol violations/deviations, and liaise with safety colleagues as needed.
• - Ensure targets, metrics, and quality are maintained per trial expectations.
• - Identify risks associated with e.g., clinical trial design, privacy and confidentiality, clinical trial misconduct, and take action to mitigate risk proactively and to escalate as appropriate.
• 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.
• Coordinate and perform translation verification of regional language, as required or as applicable per region.
• Perform site close-out visits and other site activities including archiving, as applicable.
• Mentor, coach, and train junior staff members as directed by line management.
• Perform any additional responsibilities assigned by the Line Manager and/or Project Lead.

Senior Clinical Research Associate

Director

• 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.

Associate Director – Early Phase Strategy

Clinical Project Manager, Senior Project Manager – Renal

• The Project Director (Early Phase) is responsible for oversight and supervision of all aspects of project delivery for an assigned portfolio of Early Phase projects – this portfolio may include local, regional and global clients and/or projects.
• Coordinate progress reporting for senior management, stakeholders, and clients.
• Conduct internal Monthly Project Reviews, and escalate issues as needed.
• Ensure project resource needs are identified and requested by Project Managers in timely manner.
• Oversee delivery of projects in line with customer and Emerald Clinical requirements, processes, and contracts.
• Drive consistency, efficiency, and quality across projects.
• Act as internal and client escalation point for key project issues.
• Support Project Managers to fulfill financial responsibilities for assigned projects.
• Analyse monthly project financials, identify trends, and escalate issues as needed.
• Monitor scope compliance, project performance and realization, implementing improvements where required.
• Maintain gross margin across projects in line with organizational targets.
• Oversee project forecasting and support with contingency plans for risks or delays.
• Oversee timely and accurate completion of invoicing.
• Review scope change documentation prior to submission to sponsor.
• Collaborate with internal team regarding proposals, pricing, and scope changes for assigned projects.
• Identify and pursue opportunities to expand project scope in partnership with internal teams and sponsors.
• Support project staffing to meet current and future needs.
• Recruit and onboard Early Phase staff as required.
• Monitor team performance against quality and efficiency metrics.

Project Director, Early Phase

• Develop, manage, and write strategic proposals, ensuring alignment with client requirements and company capabilities.
• Manage overall RFP process.
• Collaborate with subject matter experts, sales, and other teams to gather necessary information and transform it into tailored proposal content.
• Ensure compliance with client requests and adherence to both internal and external submission protocols.
• Maintain proposal templates and databases, ensuring accurate and up-to-date information.
• Lead proposal meetings, establish proposal timelines, and manage the proposal development process from start to finish.
• Review and edit proposal content for clarity, grammar, style, and technical accuracy.
• Manage multiple proposals simultaneously, ensuring timely completion and submission.
• Analyse proposal feedback and outcomes to continuously improve proposal strategies and processes.