About The Role
The Early Phase Associate Project Manager is a member of the Early Phase Project Management Team within Emerald Clinical who provides project management expertise for commercial and academic studies. The Associate Project Manager operates cross‐functionally to ensure the achievement of effective project outcomes and is responsible for all aspects of study management activities including cross‐functional team leadership, client communication and management, financial management and overall study delivery. The Associate Project Manager is responsible for the development, conduct and completion of some or all aspects of allocated research projects under the guidance of an experienced Project Manager or Portfolio Delivery Leader and in accordance with the reasonable requirements of the originator of the project. Manage independently or with support from Portfolio Delivery Leader 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, as well as internal project teams. Provide clear guidance to the project team on project‐specific deliverables and may also undertake site management and monitoring if previously experienced.
Project Kick‐off
* Attend relevant project‐specific meetings including formal kick‐off meetings
* Assist with development of 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
* Assist with coordination of feasibility planning and selection process of project sites
* Assist with identification of project‐specific activities that need to be outsourced and be involved in the selection of suitable vendors
* Assist with implementation, ongoing evaluation, prioritisation, reporting and timely delivery of all operational aspects of allocated projects
* Contribute to the preparation of project‐specific budget where applicable
* Track budget for allocated portion of the project
* Deliver relevant portion of project‐specific budget by guiding team and vendors on project scope, forecasting and invoicing as agreed with the 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 the 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 the project
* Monitor progress of allocated aspects of the project against timelines
* Deliver allocated project‐specific milestones as agreed with the customer
* Coordinate project administration e.g., study management committee meetings, project newsletters
* Coordinate and drive internal project team to meet allocated project‐specific deadlines; liaise with centre staff as applicable to ensure effective local management
* Work with the project team to deliver clean, accurate and verifiable data for interim and final analyses
* Assist with 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 ensure allocated team members are trained on requirements
* Provide or contribute to progress reports for project originator and other stakeholders
* Maintain regular and effective contact with allocated project team including academic leads
* Maintain contact with national coordinators working within the allocated project/region
* Be available as backup contact for site staff on all project‐related matters
* Perform site management and monitoring activities within allocated project in times of low resource availability or increased workload
* Liaise with staff in other departments including Data Management and Statistics on project‐specific deliverables as applicable
* File and archive clinical project data at end of project
Study Start‐up
* Coordinate the feasibility planning & selection process of all centers
* Manage and coordinate the establishment of study centers
* Ensure each center has the necessary trial materials
* Ensure contracts & agreements are in place
* Ensure site research coordinators are fully equipped to carry out the study
* Train site staff on data management tools and principles
* Ensure timely preparation & submission to ethics & regulatory authorities
* Develop trial management systems
* Assist with development of monitoring plans
* Manage 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 close‐out visits
* Ensure final reconciliation of clinical supplies and documentation is complete for the study
* Coordinate final archiving of study‐related documents financial & contractual
* Analyze monthly financial reports for all allocated projects to identify trends and reasons behind figures, elevate as required
* Maintain project utilization, revenue forecast and recognition; identify and implement strategies for improvement and elevate significant concerns to management
* Maintain gross margin across allocated projects to meet organisational goals
* Review forecasts for all allocated projects in consultation with each allocated project lead during month‐end billing and Project Finance Analyst meetings at least every quarter, and develop contingency plans to address project slippage
* Manage pass‐through report management to billing and ensure it is finalized within agreed timelines
* Ensure survey responses are accurate, timely and submitted within agreed timelines
* Maintain list of all scope change documentation and collaborate with Proposal team to update pricing tool & budget
* Ensure accurate completion and timely collection of data
* Ensure data quality, accuracy, completeness & 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
* Maintain project utilization, revenue forecast and recognition; identify and implement strategies for improvement and elevate any significant concerns to management
* Maintain gross margin across allocated projects to meet organisational goals
* Review forecasts for all allocated projects in consultation with each allocated project lead during month‐end billing and Project Finance Analyst meetings at least every quarter, and develop contingency plans to address project slippage
* Manage pass‐through report management to billing and ensure it is finalized within agreed timelines
* Ensure survey responses are accurate, timely and submitted within agreed timelines
* Maintain list of all scope change documentation and collaborate with Proposal team to update pricing tool & budget
About You
* 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
* Approximately five (5) years of relevant industry experience
* Prior CRA experience preferred or site management role experience, trial coordination or relevant industry experience required
* Previous experience supervising project‐related tasks of other people
* Previous exposure to client‐facing interactions and/or client management
* 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
What We Offer
* Competitive Compensation: A tailored salary and benefits package to reflect your skills and experience
* Flexibility: 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: Participation in programs and initiatives designed to promote work‐life balance, health and team connection, including global engagement surveys, recognition programmes and team‐building events
* Global Opportunities: Inclusion in a company with international reach, offering exposure to diverse projects and clients
We are an equal‐opportunity employer and encourage applications from all qualified candidates.
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