Project Manager/ Senior Project Manager (PM)

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 800+ 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 Project Manager/ Senior 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.

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