Launch Excellence Lead

Parexel International Corporation

Multiple Locations

Parexel is hiring an Launch Excellence Lead to work remotely from any location within the continental US.The role provides the overall strategy and planning for clinical trial programs and individual trials to achieve operational excellence and enable on-time and quality delivery that meets client expectations. The role acts as a subject matter and process expert for collaboration with assigned clients and provides critical path oversight of delivery, assesses trends, identifies risks and effective mitigations, and manages metrics for overall delivery. Accountability and Supporting Activities

Project Delivery Management and OversightDemonstrate strategic thinking, planning, and critical path management of clinical trial programs and individual trials for an assigned client portfolioMonitor start-up delivery performance by close interaction with project leadership/functional leadership/client and may also be required to ensure that project documentation and correspondence is accurate and completeThis may include taking the role of a senior level contributor on a project team to provide support and ensure high quality and timely delivery of own deliverables, generating study specific status reports for study teams, clients and/or management, and attending project team meetings as required at project levelProvide expertise and consultation, facilitate metrics collection, and develop action plans in conjunction with project team to keep projects on time and within budgetProvide strategic guidance to the study deployed Study Start-Up Lead / gCOL, in accordance with client expectations and/or with partnership processes

Client Management and Business DevelopmentOwn the client relationship for study launch activities at an account level, and act as a subject matter and process expert responsible for client communication and satisfaction of start-up deliveryDemonstrate a proactive approach to providing solutions for clients in a timely mannerStrategize and drive efforts for generating NBA and sustaining current client relationshipsSupport proposal review by providing strategic input on study launch activitiesParticipate in and contribute to bid defense meetings, RFIs, partnership pursuits, and other client presentations, including travel as needed

General Operations and Business Unit ManagementParticipate in department improvement activities or committees as neededEnsure implementation of process improvements in response to client and team feedback and quality auditsEncourage teamwork, quality, and productivity efforts to the benefit of Parexel overallImplement and monitor compliance with partnership processes and Parexel SOPsParticipate in departmental meetings and training initiatives, project team meetings, and maintain relationships with other departments, clients, and regulatory agencies as necessaryKeep informed of client portfolio pipeline and provide accurate forecasting as required

General AdministrationMaintain a positive, results oriented work environment, building partnerships and modeling teamwork, communicating to the team in an open, balanced, and objective mannerMaintain a working knowledge of applicable ICH Guidelines, Good Clinical Practices, Regulatory Agency requirements, and Parexel SOPsComplete routine administrative tasks in a timely manner (e.g., timesheets, training, travel expense claims) and in compliance with relevant guidelines

Skills:Strategic thinking skills that support the ability to create a sense of urgency and take a proactive, solutions-based approachExcellent analytical and problem-solving skills, to define and resolve issues in a variety of complex situationsExcellent interpersonal, verbal, and written communication skillsClient focused and demonstrating an ability to create and maintain trust with the clientAbility to resolve issues independently with good judgement to escalate appropriately Proficient in Microsoft Excel, Power Point, and Word, and project planning softwareAbility to become proficient with Parexel systemsFamiliarity with standard business and eClinical systems used in Clinical Research such as CTMS, EDC, IXRS, TMF, and project planning toolsKnowledgeable in ICH and GCP regulations in relevant geographiesDemonstrated strength in leading diverse teamsAdvanced ability to successfully manage a full workload across multiple and varied projects/tasks with enthusiasm, and prioritize workload with attention to detailOutstanding negotiation, influencing, and organizational skillsDemonstrated business acumen with ability to make difficult decisions as well as understand the business implications and potential impact on clients

Knowledge and Experience: Fluent in written and oral English and local languageKnowledge in clinical research industry, including expert understanding of study start-upSignificant work experience in a CRO/Pharma setting including substantial client management experience

Education:Educated to degree level (biological science, pharmacy, or other health-related discipline preferred) or other equivalent clinical experience


2023-01-25 00:05:26

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