Senior Project Manager (Early Phase Clinical Trials), Australia
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 20pharmaceutical 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 Early Phase 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 Early Phase Senior 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. Senior 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). May be responsible for delivery and management of larger global studies. Manage independently or with support from (Associate) Project Directors or Line Manager. The Senior Project Manager mentors/coaches Junior Project Management staff or Clinical Lead and assists their technical development.
Responsibilities
Staff Development & Training
• Manage staff associated with the project and lead the objective setting, performance management, training & development and position review processes for these positions e.g. Clinical research Associates (CRAs)
• Participate in team meetings and activities related to Emerald Clinical, in order to improve processes, tools & systems within the organisation
• Mentor/coach PM/ Clinical staff including regular co-monitoring visits as needed
• Assist in the recruitment of the project clinical team Study Start-up
• Co-ordinate the feasibility planning & selection process of all centres
• Manage and coordinate the establishment of study centres through:
o Ensuring each centre has the necessary trial materials
o Contracts & agreements are in place
o Ensuring site research coordinators are fully equipped to carry out the study
o Training site staff on data management tools and principles
o Ensure the timely preparation & submission to ethics & regulatory authorities.
o Develop trial management systems
o Assist with the development of monitoring plans
o Manage the planning & set-up of investigator meetings; prepare presentation material & present information at these meetings
Study Execution
• Manage the project to ensure that all participating centres meet requirements relating to:
• Data quality, accuracy, completeness and timeliness
• Complete and efficient resolution of data queries
• Adherence to the study protocol and study procedures manual
• Adherence to ICH/GCP and other guidelines and requirements as relevant to this trial
• Accurate and detailed reports from monitoring visits are kept for scrutiny by Management Committee and external auditors
• Manage and supervise the monitoring visit schedules for the CRAs & that visits (selection, initiation, monitoring & close-out) are carried out according to the study design
• Review and sign-off the monitoring visit reports
• Ensure the study is conducted in accordance with study protocol and procedures manual, applicable regulatory requirements, local ethics committee requirements and ICH-GCP guidelines
• Manage all documentation for the project (including but not limited to all GCP requirements, contact details, signed contracts, serious adverse event reports and ethics committee reports)
• Oversee the on-going management of the participating sites to ensure adequate recruitment, data quality & timely CRF completion by investigators.
• Identify areas requiring follow up and improvement at each clinical study site and recommend corrective action
• Participate in the scheduled project meetings or teleconferences with the staff in the organisation
• Ensure effective communication is maintained with all investigators, site staff, study staff and the operational team
Study Close-out
• Work with the clinical team to ensure timely & successful completion of trial
• Coordinate the study close-out 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
Team Leadership
• Mentor and coach junior staff or functional leads in their role and responsibilities for project delivery and project team oversight
• Establish and maintain a culture focused on high performance and continuous improvement within project team
• Model and inspire understanding and adherence to the values of the organisation
• Ensure allocated staff are working as a cohesive team and an effective team communication plan is in place
• Provide clear guidance to functional leads or other staff on project specific deliverables.
• Develop and foster a collaborative teamwork approach within project team/s
• Attend, lead and actively participate in project meetings.
• Attend and actively contribute to all Emerald Clinical meetings and events and other internal meetings as required
Financial and Contractual
• Analyze monthly financial reports for all allocated projects to identify trends and reasons behind figures, escalate as required.
• Ensure project managers 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 manager, 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
• 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 regional/ global studies.
About You
• Bachelor’s or Masters degree in a science or related field Previous experience managing clinical research trials/projects
• Relevant work experience recommended for this role may be approximately (9) years of industry experience; prior CRA experience preferred or site management role experience, trial coordination or relevant industry experience required
• Experience managing early phase studies (Phase I/IIa), including healthy volunteer and oncology studies, is essential
• Previous exposure to client-facing interactions and/or client management
• Project finance management experience, CRO preferred
• Ability and motivated to learn and develop, including sharing knowledge with others
• Ability or previous experience managing and developing people.
• Excellent working knowledge of ICH/GCP, ethical and regulatory requirements
• Understanding of the importance of data quality and accuracy in health research and clinical trials. • Ability to provide professional and comprehensible telephone support to study staff and their colleagues at participating hospitals
• Understanding of confidentiality and privacy laws and all guidelines relevant to medical research.
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.
- Department
- Project Management
- Locations
- Adelaide, Australia, Australia, Brisbane, Australia, Melbourne, Australia, Sydney, Australia
- Remote status
- Hybrid