Project Manager (Early Phase) - Mandarin Speaking

Emerald Clinical Trials • Lisbon, North America

2h • $155,000 - $175,000 • Hybrid

About The Position

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.

Requirements

• 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 may be approximately seven (7) years of industry experience, with 1-2 years of PM experience
• Proficiency in Mandarin is a mandatory requirement for this role
• Prior CRA experience preferred or site management role experience, trial coordination or relevant industry experience required
• Experience managing single or different regions, working across different therapeutic indications, managing full-service studies, worked on early phase clinical trial
• 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
• Must be able to work APAC hours

Nice To Haves

• Experience in managing early-phase and healthy volunteer studies are plus, not mandatory.

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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level