At Emerald Clinical, we are a global, full-service Contract Research Organization (CRO) with a rich heritage in the Asia-Pacific region. We are dedicated to advancing clinical research through scientific expertise and operational excellence, supporting biopharmaceutical, medical device, and diagnostic customers across all trial phases, from registration to post-marketing.

Our therapeutic expertise spans renal, cardiometabolic, and oncology-areas where we make a significant impact on improving global health.

At the heart of our success is our ability to combine global reach with local knowledge. Our on-the-ground teams work closely with local communities, building trust and ensuring diverse, representative patient recruitment. By prioritizing people, we deliver better engagement, more accurate data, and faster results-bringing therapies to patients in need.

About the Role

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.

Your Responsibilities

All activities must be conducted in accordance with project specific documentation, applicable SOPs, ICH GCP and applicable regulatory requirements.

Maintain effective professional relationships with external customers, investigators and vendors. Maintain effective professional relationships with internal project team including those providing academic input.

Provide clear guidance to project team on project specific deliverables.

Project Kick-off

Attend relevant project specific meetings including formal kick-off meetings

Develop project plan and other internal project management documents. Assist the originator of the project in the development of project specific documents such as protocol and participant information forms as requested.

Coordinate the feasibility planning and selection process of project sites

Identify project specific activities that need to be outsourced and be involved in the selection of suitable vendor/s.

Project Implementation and Closure

Manage the implementation, ongoing evaluation, prioritisation, reporting and timely delivery of all operational aspects of allocated project/s including:

Contribute to the preparation of project specific budget where applicable

Track budget for allocated portion of project

Deliver relevant portion of project specific budget by guiding team and vendors on project scope, and forecasting and invoicing as agreed with customer

Track project scope and propose scope changes for assessment

Work with relevant personnel to identify potential clinical sites, oversee or conduct feasibility through questionnaire, interview and/or site visit as applicable

Oversee the set-up of sites within relevant region in accordance with SOPs, protocol and all applicable regulatory guidelines

Contribute to the calculation of project staffing levels

Contribute to the identification of appropriate materials for project

Monitor project progress against timelines

Deliver project specific milestones as agreed with customer

Coordinate project administration e.g. study management committee meetings, project newsletters

Coordinate and drive internal project team to meet project specific deadlines

Liaise with centre staff to ensure effective local management

Drive project team to deliver clean, accurate and verifiable data for interim and final analyses

Assist with the development of project documentation e.g. site manuals, operating procedures

Review and sign-off monitoring visit reports

Ensure patient safety and adverse/serious adverse events are reported according to regulatory requirements

Initiate filing conventions for the project and team is trained on requirements

File and archive clinical project data at end of project

Provide or contribute to progress reports for project originator and other stakeholders

Maintain regular contact with project team including academic leads

Maintain contact with National Coordinators working within allocated region

Be available as back-up contact for site staff on all project related matters

Where applicable liaise with staff in Data Management and Statistics • Divisions on project specific deliverables

Study Start-up

Co-ordinate the feasibility planning & selection process of all centers

Manage and coordinate the establishment of study centers through:

Ensuring each center has the necessary trial materials

Contracts & agreements are in place

Ensuring site research coordinators are fully equipped to carry out the study

Training site staff on data management tools and principles

Ensure the timely preparation & submission to ethics & regulatory authorities.

Develop trial management systems

Assist with the development of monitoring plans

Manage the planning & set-up of investigator meetings; prepare presentation material & present information at these meetings

Study Close-out

Work with the clinical team to ensure timely & successful completion of trial Coordinate the study closeout visits

Ensure final reconciliation of clinical supplies and ensure that all clinical supplies' documentation is complete for the study

Coordinate the final archiving of study related documents

Data Management

Ensure the accurate completion and timely collection of data

Ensure data quality, accuracy, completeness and timely data completion

Ensure complete and efficient resolution of data queries

Manage the study to ensure adherence with all protocol, SOPs, regulations & ICH-GCP

Ensure distribution and collection of essential documents, reports and study materials and products to and from clinical sites.

Financial and Contractual

Analyze monthly financial reports for all allocated projects to identify trends and reasons behind figures, escalate as required.

Understand all aspects of their project finance responsibilities and follow appropriate escalation pathways

Maintain project utilization, revenue forecast and recognition identify and implement strategies for improvement (if required) and escalate any significant concerns to management

Maintain gross margin across allocated projects to meet organizational goals.

Review forecasts for all allocated projects in consultation with each allocated project lead, as needed, during month end billing and Project Finance Analyst meetings at least every quarter and develop contingency plans to address any project slippage

Manage pass through report management to billing is finalized within agreed timelines

Manage project review reporting to ensure survey responses are accurate, timely and submitted within agreed timelines

Maintain list of all scope change documentation, collaborate with Proposal team to update pricing tool/budget .Seek opportunities for expansion of scope and proactively follow up with BD & Sponsor.

Customer Focus and Business Development

Initiate and maintain high level relationships with internal and external stakeholders, including trial sponsor staff, key opinion Leaders, hospitals, professional societies and associations where required.

Review and contribute to all scope change proposals for allocated projects prior to finalisation and sponsor review

Participate in bid defense presentations in partnership with Business Development and may lead the presentation for smaller, less complex regional studies.

Quality Management

Ensure allocated projects are conducted in accordance with the Emerald Clinical Quality Management Strategy.

In the event of an audit and/or inspection work with key project team members to ensure inspection/audit readiness and complete follow-up for all team members

Ensure compliance with file reviews plan and documentation as specified by Sponsor and/or Emerald Clinical

Ensure co-monitoring activities conducted in accordance with Sponsor and/or Emerald Clinical requirements

Ensure own quality control of all relevant processes and activities performed

Systems, Compliance and Training

Ensure allocated project team members remain compliant with project SOP and training curricula

Maintain up to date technical knowledge through attending appropriate local and Global conferences and meetings

Ensure compliance with timesheet completion and review across teamTraining, Quality and Compliance

Complete mandatory training for this role within specified timelines

Attend mandatory training sessions required for this role

Identify resources and training to support learning and development within this role

Comply with all applicable regulations, guidelines, SOPs and project-specific requirements

Comply with all designated systems relevant to this role

Ensure own quality control of all relevant processes and activities performed

Report and escalate identified risks and issues in areas of responsibility according to Emerald Clinical and/or project requirements

Customer Focus and Teamwork

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

Work Health and Safety

Comply with Work Health & Safety (WH&S) legislation and operate in accordance with established organizational WH&S practice and procedures

Promote and contribute to a safe, secure environment for staff and visitors

About You

Bachelor's or Masters degree in a science or related field

Previous experience working on clinical projects within an academic, CRO or pharmaceutical company environment

Relevant work experience recommended for this role includes approximately seven (7) years of industry experience. A minimum of two (2) years of Project Management experience within the CRO industry is mandatory. Prior experience as a CRA, in site management, trial coordination, or other relevant industry experience is preferred.

Experience managing single or different regions, working across different therapeutic indications, managing full-service studies, worked across early phase to Late phases of clinical trial, is preference

Excellent working knowledge of, and ability to implement project activities in accordance with, ICH/GCP and all applicable regulations and guidelines in the relevant regions.

Previous exposure to client-facing interactions and/or client management

Project finance management experience, CRO preferred

Previous experience supervising project related tasks of other people

Excellent working knowledge of, and ability to implement project activities in accordance with, ICH/GCP and all applicable regulations and guidelines in the relevant regions

Technological proficiency including Microsoft Office suite (Word, Excel, PowerPoint, Outlook, Project), clinical trials management software, and the Internet

Competencies

Excellent interpersonal skills, presentation skills and team Leadership ability including leading virtual teams in a cross-cultural environment and dealing with conflict

Strong communication skills (written and verbal), including excellent presentation skills Expert knowledge of ICH-GCP guidelines, global and local ethical and regulatory research requirements for assigned studies

Ability and motivated to learn and develop, including sharing knowledge with others

Familiarization with project finance management

Ability and motivated to learn and develop, including sharing knowledge with others

Ability to see the big picture, yet still focus on detail and quality of work

Ability to be flexible and adaptable in the face of changing organisational priorities and ambiguous environments

Additional requirements

Ability and willingness to travel domestically & globally (up to 25%, as required)

Why Join Us?

At our core, Emerald Clinical Trials is committed to transforming clinical research by putting people first-both patients and our employees. By joining our team, you'll be part of a global network of passionate professionals working together to deliver better research and outcomes for millions worldwide.

Here's what makes us stand out:

• Purpose-Driven Work: You'll contribute to clinical trials that genuinely improve lives, with a focus on therapies in renal, cardiometabolic, and oncology.

• Global Reach, Local Expertise: Our teams connect with local communities, building trust and meaningful engagement for every trial.

• Collaboration and Innovation: Work in a culture that values diverse perspectives and creative solutions to solve global health challenges.

What We Offer

We understand that great work happens when people feel valued and supported. That's why we provide:

• Competitive Compensation: A tailored salary and benefits package to reflect your skills and experience.

• Flexibility: Enjoy hybrid or remote working arrangements, depending on your location and role.

• Career Growth: Access to a wealth of learning opportunities and a global network of scientific leaders to help you grow and develop in your role.

• Employee Wellbeing: Participate in programs and initiatives designed to promote work-life balance, health, and team connection, including global engagement surveys, recognition programs, and team-building events.

• Global Opportunities: Be part of a company with international reach, offering you exposure to diverse projects and clients.

Interested? Apply now and help us achieve our mission to improve the health of millions worldwide.

We are an equal-opportunity employer and encourage applications from all qualified candidates.

Locations United Kingdom, Romania, Portugal, Poland, Ireland, Ireland Remote status Fully Remote