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Project Manager

hace 8 días

Donostia / San Sebastián

At Emerald Clinical , we are a global, full-service Contract Research Organization (CRO) with a rich heritage in the Asia-Pacific region. We are dedicated to advancing clinical research through scientific expertise and operational excellence, supporting biopharmaceutical, medical device, and diagnostic customers across all trial phases, from registration to post-marketing. Our therapeutic expertise spans renal , cardiometabolic , and oncology —areas where we make a significant impact on improving global health. Obtenga más información sobre las tareas generales relacionadas con esta oportunidad a continuación, así como sobre las habilidades requeridas. At the heart of our success is our ability to combine global reach with local knowledge. Our on-the-ground teams work closely with local communities, building trust and ensuring diverse, representative patient recruitment. By prioritizing people, we deliver better engagement, more accurate data, and faster results—bringing therapies to patients in need. About the Role The 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 Your 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 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 these meetings Study Close-out 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 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. Financial and Contractual 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 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 smaller, less complex regional studies. Quality Management 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 Systems, Compliance and Training Ensure allocated project team members remain compliant with project SOP and training curricula Maintain up to date technical knowledge through attending appropriate local and Global conferences and meetings Ensure compliance with timesheet completion and review across teamTraining, Quality and Compliance About You 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 Relevant work experience recommended for this role includes approximately seven (7) years of industry experience. A minimum of two (2) years of Project Management experience within the CRO industry is mandatory. Prior experience as a CRA, in site management, trial coordination, or other relevant industry experience is preferred. Experience managing single or different regions, working across different therapeutic indications, managing full-service studies, worked across early phase to Late phases of clinical trial, is preference 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. xcskxlj We are an equal-opportunity employer and encourage applications from all qualified candidates.

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