Disclaimer:
This requisition is currently open for talent pooling purposes. The role is not yet available, but we will review applications and contact suitable candidates as soon as the position becomes available.
Who We Are
Emerald Clinical Trials is a
global leader
in clinical research, partnering with over
160 biotech
companies and
15 of the world's top 20
pharmaceutical firms. Headquartered in Singapore, we combine scientific excellence with operational expertise to deliver end-to-end clinical trial solutions across all phases, offering
Phase I-IV and real-world studies
.
With over
25 years of experience
and a
world-renowned focus in renal research
, Emerald Clinical has helped drive medical breakthroughs through deep scientific insight, flawless execution, and an unwavering commitment to quality.
Global Expertise. Local Insight. Real Impact.
Emerald Clinical is where science, speed, and strategy come together to transform healthcare. For over 25 years, we have led the way in clinical research, combining global reach with deep Asia-Pacific expertise and unparalleled local insight to deliver smarter trials and stronger outcomes.
Our
****+ employees that span across Asia-Pacific, Europe, and the Americas
are embedded in communities worldwide. We drive faster recruitment, deeper patient engagement, and meaningful results that move medicine forward.
About The Role
The
Early Phase 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 Early Phase 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.
Early Phase 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.
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
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/responsible 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, elevate 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 elevate 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
#J-*****-Ljbffr

📌 Project Manager (Early Phase) - - Talent Pipeline Opportunity (Brisbane)
🏢 Emerald Clinical
📍 Brisbane