Senior Clinical Project Manager
3 giorni fa
Senior Clinical Project Manager - Europe UBC is a pharmaceutical support industry leader devoted to empowering health solutions for a better tomorrow.We take pride in improving patient outcomes and advancing healthcare.At UBC, we provide services to enhance the entire drug development process and commercialization lifecycle – from clinical trial support to real-world evidence generation.Embark on a rewarding career journey with UBCGrow your career while making a meaningful impact on the world around you.UBC fosters a culture built on our core values of Respect, Accountability, Innovation, Quality, Integrity, and Collaboration.We believe in an inclusive workplace that encourages creativity.Brief DescriptionThe EU PM is responsible for providing operational oversight of assigned UBC projects.The EU PM will have a leading role in planning, coordinating and completing project work.The EU PM will work closely with external clients/sponsors, internal project team members, vendors, and suppliers to ensure satisfactory delivery of contracted services and achievement of contracted milestones for assigned projects.The EU PM will ensure that projects are conducted in a timely manner to achieve project goals within defined budgets.Supervisory ResponsibilitiesSupervision of project teamSupervise project management staff in execution of assigned studiesEnsure that the PAds, PAs, APMs, PMs, project team members understand the client needs once a project is awardedServe as a resource and mentor to the PA/APM in the execution of their daily activitiesProactively assist the PA/APM in anticipating and seeking resolutions to potential and actual project issuesSpecific Job DutiesOversee the day-to-day management of European and/or multi-national global projectsManage project per the scope of work and within the contracted budgetOversee all aspects of project conduct from start-up through close-outPrepare project timelines and coordinate project development of deliverablesEnsure project is conducted according to UBC and client SOPsEnsure conduct of project related training and record keepingServe as the UBC primary contact with the sponsor for all project related itemsCoordinate project meetings including investigator meetings and client meetingsLead internal and external project meetingsEnsure project budget is tracked against contract milestonesManage project budget and resource expenditures including invoicing, analyzing cost variances, out-of-scope management, and conducting revenue recognitionDevelop project plans to achieve contracted milestones (i.e. project plan, risk management plan, site management & monitoring plan, training plan, communication plan, etc.)Monitor project progress against the established plans and ensure compliance with plansSupervise and provide direction to assigned project team members including PAs, APMs, Clinical Research Associates (CRAs), Clinical Site Specialists (CSS), Regulatory Associates (RA)Focal point for resolving project team member questionsPrepare and negotiate investigator/site/vendor budgets and assist with remediation of contract languageProvide operational input and participate in the design and review of study protocols, case report forms (CRFs), study reports, and other functional documents and plans in collaboration with project teamCoordinate development of patient/subject consent forms and site/patient materialsEnsure Trial Master File (TMF/eTMF) is maintained and audit-ready on ongoing basisMonitor and ensure project team compliance with maintenance of Clinical Trial Management System (CTMS)Completion of departmental oversight trackers for projects (e.g. functional resource forms, project review form, project execution checklist)May be asked to perform Lead CRA or CRA duties on projects as neededParticipate in internal UBC process improvement initiativesPrepare and participate in presentations to clients in defence of proposalsPresent project information at bid defences, client meetings and UBC internal project governance and review meetingsOther duties as assigned by managementEducation/ExperienceMinimum a Bachelor's degree or equivalent in a clinical, scientific, or related field, with an advanced degree desirable, or sufficient, relevant job experience, or another relevant education2 to 3 years direct project management experience at a Contract Research Organisation (CRO) or 5 or more years of clinical trial experienceHas proven working experience and understanding of working within clinical researchKnowledge of the key principles of cross-functional project managementTechnical/KnowledgeProficient in use of web based IT systems (e.g. CTMS or electronic Case Report Forms) and Microsoft (MS) Excel, MS PowerPoint, and MS WordExperience using project management software (e.g. MS Project)Ability to effectively use automated systems and computerized applicationsVery good knowledge of regulatory requirements for research conduct (i.e. Good Clinical Practice, International Conference on Harmonization (ICH) guidelines, etc.)Excellent working knowledge of clinical research/development, including medical and therapeutic areas, phases and medical terminologyKnowledge of CRO/Pharmaceutical functional departments and responsibilitiesGood quantitative skills and working understanding of project budgets (solid financial acumen)Proficient in local language (oral and written) and profound working knowledge of the English language (oral and written)AttributesExcellent communication skills and ability to communicate effectively with all levels of an organizationExcellent interpersonal, verbal and written communication skillsAble to lead, motivate and coordinate teamsExcellent planning and problem solving skillsAble to delegate, effectively prioritizes own and workload of project team membersFlexible and adaptable to changing situationsVery good supervisory skillsVery good presentation skillsExcellent organisational and time management skillsProficient at multi-tasking with good attention to detailHas experience with leading, liaising and coordinating cross-functional project teams10% travelSeniority levelMid-Senior levelEmployment typeFull-timeJob functionProject Management and Information Technology#J-*****-Ljbffr
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