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19.10.2016

Principal Clinical Trial Manager (CAR-T Therapy Studies)
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Job Description:

Description Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries - and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture. Summary/Scope: The Principal Clinical Trial Manager provides leadership and oversight of the clinical research program(s) to ensure delivery on time, within budget, and of high quality in compliance with ICH/GCP, Regulatory Authorities' regulations/guidelines, and applicable SOPs/WPs. Responsibilities include providing strategic operational direction, execution of complex study(ies) and/or oversight of multiple cross-functional study team(s) and performance and quality oversight of the associated Contract Research Organization (CRO) teams. They should be able deliver high caliber presentations to senior and executive leadership within and outside of Celgene (as appropriate). The Principal clinical trial manager is expected to consistently demonstrate strategic critical thinking skills for problem solving and have the lateral and insightful thinking capacity to drive the study(ies) and understanding the upstream, downstream and lateral implications of decisions that affect study outcomes and timelines. The Principal clinical trial manager has overall accountability for the execution of the Clinical Operations strategy for the program(s) and /or studies which may include but is not limited to the following: Program Management • Provision of guidance on operational program implementation and management • Accountable for ensuring that program-specific standards are developed and applied across trials [in line with portfolio-level standards] to ensure consistency and efficiency • Driving the operational program strategy in close interaction with CRO partners • Active contribution to the scientific and operational feasibility as well as oversight and alignment of activities of the internal and external operational team members contributing to the program • Reports to senior management as needed with regards to all matters of clinical program implementation • Leading/driving collaboration with CRO partner(s) for program operational delivery to ensure meeting expected timelines, budget, and quality in alignment with Celgene expectations and standards • May represent Clinical Operations within the global project team Financial Planning and Project Management • Drive the early planning of study / program timelines and budgets through close collaboration with other functions (e.g. Clinical, Clinical Trial Analytics, PSRM, Finance, Data Management, IMSC and other relevant functions) • Takes ownership and accountability for development and management of study and/or program level budgets • Collaborate closely with Project Leadership to ensure that timelines and budgets are appropriately presented to governance committees. • Notify Clinical Trial Management Leadership (and other relevant functions) of resource requirements for new studies • Support identification and resolution of issues related to study timelines and budgets • Lead regular (e.g. quarterly) program budget review meetings with Finance and ensure that anticipated budget deviations are flagged. • Review study planning and tracking tools regularly (including study budgets), flag deviations to relevant stakeholders and develop mitigation plans in collaboration with Clinical Trial Managers and other relevant functions • Development/management/reconciliation of overall program budget(s) or oversight thereof • Development/management/reconciliation of CRO partner scope of work (SOW) per contract, quality, and budget • Oversight of review/approval of clinical service provider (vendor) invoices and management of accruals and SOW changes. • Oversight of program execution utilizing available performance metrics and quality indicators • Oversight of development and management of key program milestones and deliverables through collaboration with internal and external stakeholders • Proactive identification/assessment of potential risks at program level and oversight of development/implementation of actions to avoid or mitigate • Oversight of the maintenance/updating of data as appropriate in study management tools including CTMS • Informing leadership (as appropriate) on overall clinical program progress, updated forecasting, and of potential issues/mitigation • Excellence in identification of potential risks and development/implementation of actions to avoid or mitigate and able to make the appropriate trade-offs of balancing risks with study deliverables and costs. Program Planning and Conduct • Operational input into program and study level planning and docume



 
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