Emerald Clinical

Director

• 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

Manager

• 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.

Proposals Manager

Clinical Research

• Oversee clinical trials, ensuring successful execution from start-up to close-out.
• Lead site selection and feasibility assessments, working closely with CRAs and investigators.
• Manage study timelines, budgets, and deliverables, ensuring adherence to project objectives.
• Provide oversight on protocol administration, site initiation, monitoring, and study progress.
• Collaborate cross-functionally with internal and external stakeholders, including sponsors, investigators, and project teams.
• Ensure compliance with GCP, FDA regulations, and company SOPs.
• Train and mentor CRAs and site staff, ensuring protocol adherence and data integrity.

Clinical Lead – Clinical Trial Manager, Renal

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

Clinical Lead – Clinical Trial Manager

Project Manager

• The Project Manager is responsible for the development, conduct and completion of research projects in accordance with the reasonable requirements of the originator of the project.
• The Project Manager is responsible for all aspects of study management activities including cross functional team Leadership and co-ordination, Client communication/ management, financial management and Overall study delivery.
• Project Manager must ensure studies are resourced effectively, managed efficiently, achieve project objectives within allocated budgets and agreed timelines and are conducted to the highest standards of Good Clinical Practice (GCP), regulatory requirements and applicable Standard Operating Procedures (SOP).
• The Project Manager mentors/coaches Junior Project Management staff or Clinical Delivery Leads and assists their technical development.
• Manage independently or with support from Portfolio Delivery Leads or Line Manager.

Senior Project Manager/Project 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

General Counsel

• Lead, maintain, and continuously enhance Emerald’s global privacy framework, including policies, procedures, and operational processes.
• Oversee and coordinate privacy operations supporting Emerald’s global clinical trials, with a particular focus on APAC, EU, and the US.
• Perform and manage data transfer impact assessments and oversee cross‑border data transfer mechanisms.
• Provide day‑to‑day privacy support across the business, including: Responding to internal queries, Supporting customer audits, Advising on data retention and local privacy requirements.
• Review, negotiate, and advise on data processing agreements, data transfer agreements, security annexes, and related contractual documentation.
• Maintain and manage Emerald’s records of processing activities.
• Own and manage data subject rights requests, data incident risk assessments, and breach notification processes.
• Support Legal with privacy‑related complaints, investigations, and potential litigation, including interactions with regulators where required.
• Conduct privacy compliance reviews and present findings to relevant internal stakeholders.
• Advise on privacy requirements for new business initiatives, including review of privacy notices and regulatory compliance considerations.
• Support the Group General Counsel on complex or escalated privacy matters.
• Design and deliver ongoing privacy training to Emerald personnel globally.
• Work collaboratively across regions and time zones, escalating issues appropriately to internal leadership or external counsel when necessary.

Global Privacy Counsel

Business Development Rep

• Develop and execute a targeted outbound sales plan to drive adoption of our overseas clinical trial solutions among American biotech and pharma companies.
• Identify and engage American sponsors actively exploring or planning global or multi-regional clinical trials.
• Position the company as the strategic partner of choice for American innovators seeking to expand into international markets through robust clinical data.
• Proactively connect with decision-makers in American biopharma firms via direct outreach, industry conferences, and professional networks.
• Lead compelling capability presentations and solution workshops highlighting our global operational footprint, regulatory success stories, and therapeutic expertise.
• Collaborate with internal teams (proposal team, clinical operations, regulatory, biometrics, etc.) to develop tailored proposals and budgets for overseas trials sponsored by American clients.
• Lead contract negotiations, ensuring alignment with company profitability and legal guidelines.
• Track trends in USA's biopharma sector, including outbound investment, globalization strategies, and regulatory.
• Monitor competitor offerings targeting clients and identify differentiation opportunities.

Senior Business Development Director

• The Project Manager is responsible for the development, conduct and completion of research projects in accordance with the reasonable requirements of the originator of the project.
• The Project Manager is responsible for all aspects of study management activities including cross functional team Leadership and co-ordination, Client communication/ management, financial management and Overall study delivery.
• Project Manager must ensure studies are resourced effectively, managed efficiently, achieve project objectives within allocated budgets and agreed timelines and are conducted to the highest standards of Good Clinical Practice (GCP), regulatory requirements and applicable Standard Operating Procedures (SOP).
• The Project Manager mentors/coaches Junior Project Management staff or Clinical Delivery Leads and assists their technical development.

Clinical Project Manager / Senior Project Manager

Account Manager

• Proactively identify, research, and qualify potential new clients within the pharmaceutical, biotech.
• Initiate and maintain contact with prospective clients through phone, email, and virtual meetings
• Conduct needs assessments to understand client requirements and pain points
• Present the company's services, capabilities, and value proposition effectively
• Manage the sales pipeline and maintain accurate records in the CRM system
• Provide timely updates to the sales leadership on pipeline activity and forecasts
• Collaborate with Business Development Managers / Directors to ensure smooth handoff of qualified leads.
• Monitor industry trends, competitor activities and new developments to identify new opportunities.
• Build and maintain strong relationships with prospective and existing clients.
• Attend and actively participate in Emerald Clinical meetings and other internal meetings and activities as required
• Provide input to systems, tools and processes to support continuous improvement
• Share knowledge with others, to facilitate learning and development across the organization

BD Account Manager

• Increase proficiency in Trial Master File (TMF) set-up and maintenance (filing), both hard copy and electronic as assigned by project.
• Increase proficiency in uploading and maintaining TMF files and folders in George Clinical’s file-sharing system by project as assigned.
• Serve as second reviewer for TMF QC.
• May function in the TMF Lead Role and assume responsibility for TMF setup, maintenance and oversight.
• Assist with/complete end of study TMF filing (including site close out documents), QC and archival.
• Further develop skills in preparing and participating in audit responses.
• Perform QC of work (documents, emails etc.) prior to sending out to ensure quality product deliverables.
• Further develop skills and knowledge of data entry and maintaining files/folders for Clinical Trial Management System by project as assigned.
• Further develop skills and knowledge of assisting with data entry support, tracking and submission for investigator payments by project as assigned.
• Works with CRA/CTM/PM during site start-up for feasibility, serving as point of contact for sites where applicable.
• Assist with presenting final feasibility results to PM team and/or Sponsor.
• Assists the sites in preparation, planning, organizing and collecting essential document packets (EDPs).

Project Director, Early Phase

Proposals Manager

Clinical Lead – Clinical Trial Manager, Renal

Clinical Project Manager – Renal

Clinical Lead – Clinical Trial Manager

Senior Project Manager/Project Manager

Clinical Research Associate 2

Global Privacy Counsel

Senior Business Development Director

Clinical Project Manager / Senior Project Manager

Clinical Research Associate 2

BD Account Manager

Clinical Trial Specialist