Project Manager (Early Phase) - - Talent Pipeline Opportunity at Emerald Clinical Trials | AU | Rezi

Project Manager (Early Phase) - - Talent Pipeline Opportunity at Emerald Clinical Trials

Project Manager (Early Phase) - - Talent Pipeline Opportunity

Emerald Clinical Trials · AU

1 weeks ago

Project Manager (Early Phase) - - Talent Pipeline Opportunity

Emerald Clinical Trials · AU

12 days ago
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About the Role

The Early Phase Project Manager is responsible for the development, conduct, and completion of research projects, ensuring effective resource management, efficient operations, and adherence to project objectives within budget and timelines. This role involves leading cross-functional teams, managing client communication, overseeing financial aspects, and ensuring the highest standards of Good Clinical Practice (GCP) and regulatory compliance. The Project Manager also mentors junior staff and collaborates with various internal and external stakeholders.

Responsibilities

  • Conduct all activities in accordance with project-specific documentation, SOPs, ICH GCP, and regulatory requirements.
  • Maintain professional relationships with external customers, investigators, vendors, and internal project teams.
  • Provide clear guidance to the project team on project-specific deliverables.
  • Coordinate feasibility planning and site selection processes.
  • Identify and manage outsourced project activities and vendors.
  • Manage project implementation, evaluation, prioritization, reporting, and timely delivery of operational aspects.
  • Contribute to project budget preparation, tracking, and forecasting.
  • Track project scope and manage scope changes.
  • Oversee site setup in accordance with SOPs, protocol, and regulatory guidelines.
  • Contribute to project staffing level calculations and material identification.
  • Monitor project progress against timelines and deliver project milestones.
  • Coordinate project administration, including meetings and newsletters.
  • Drive the project team to meet deadlines and deliver clean, accurate data.
  • Assist with the development of project documentation, such as site manuals.
  • Review and sign-off on monitoring visit reports.
  • Ensure patient safety and proper reporting of adverse events.
  • Initiate and train teams on filing conventions, and archive clinical project data.
  • Provide progress reports to project originators and stakeholders.
  • Maintain regular contact with project teams, academic leads, and National Coordinators.
  • Serve as a backup contact for site staff.
  • Liaise with Data Management and Statistics divisions on project-specific deliverables.
  • Coordinate and manage the establishment of study centers, ensuring necessary materials, contracts, and staff training are in place.
  • Ensure timely preparation and submission to ethics and regulatory authorities.
  • Develop trial management systems and assist with monitoring plan development.
  • Manage the planning and setup of investigator meetings.
  • Coordinate study closeout visits and ensure final reconciliation of clinical supplies and documentation.
  • Ensure accurate and timely data collection, quality, and query resolution.
  • Manage the study to ensure adherence to protocol, SOPs, regulations, and ICH-GCP.
  • Ensure distribution and collection of essential documents, reports, and study materials.
  • Analyze monthly financial reports, identify trends, and escalate issues as required.
  • Understand and manage project finance responsibilities and escalation pathways.
  • Maintain project utilization, revenue forecast, and recognition, implementing improvement strategies.
  • Maintain gross margin across allocated projects to meet organizational goals.
  • Review project forecasts and develop contingency plans.
  • Manage pass-through report management to ensure timely billing finalization.
  • Ensure accurate and timely submission of survey responses.
  • Maintain scope change documentation and collaborate with the Proposal team on pricing and budgets.
  • Seek opportunities for scope expansion and follow up with Business Development and sponsors.
  • Initiate and maintain high-level relationships with internal and external stakeholders.
  • Review and contribute to scope change proposals.
  • Participate in bid defense presentations and potentially lead presentations for smaller studies.
  • Ensure allocated projects comply with the Emerald Clinical Quality Management Strategy.
  • Ensure inspection/audit readiness and complete follow-up actions.
  • Ensure compliance with file review plans and documentation requirements.
  • Ensure co-monitoring activities align with Sponsor and/or Emerald Clinical requirements.
  • Perform quality control of all relevant processes and activities.

Requirements

  • Bachelor’s or Master’s degree in a science or related field.
  • Previous experience working on clinical projects within an academic, CRO, or pharmaceutical company environment.
  • Approximately seven (7) years of industry experience, with 1-2 years of PM experience.
  • Prior CRA experience preferred or site management role experience, trial coordination, or relevant industry experience required.
  • Experience in managing early-phase and healthy volunteer studies is a plus, not mandatory.
  • Experience managing single or different regions, working across different therapeutic indications, managing full-service studies, and worked on early phase clinical trials.
  • 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.
  • 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.

Skills

  • Project Management
  • Clinical Research
  • GCP
  • ICH GCP
  • Regulatory Requirements
  • SOPs
  • Client Communication
  • Financial Management
  • Team Leadership
  • Cross-cultural Team Leadership
  • Conflict Resolution
  • Communication Skills
  • Presentation Skills
  • Data Management
  • Site Management
  • Trial Coordination
  • Early-Phase Studies
  • Healthy Volunteer Studies
  • Full-Service Studies
  • Bid Defense
  • Quality Management
  • Audit Readiness

Location

  • Singapore

Work Type

  • Hybrid
  • Remote

Experience Level

  • 7 years industry experience
  • 1-2 years PM experience

Education Level

  • Bachelor's degree in science or related field
  • Master's degree in science or related field

Benefits

  • Competitive Compensation
  • Flexibility
  • Career Growth opportunities
  • Employee Wellbeing programs
  • Global Opportunities

About the Company

  • 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 1000+ 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.
  • 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.
  • 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.

Equal Opportunity

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