Sr Project Mgr Fsp | Thermo Fisher Scientific |ItalyJob DescriptionAt Thermo Fisher Scientific, you'll discover meaningful work that makes apositive impact on a global scale. Join our colleagues in bringing our...At Thermo Fisher Scientific, you'll discover meaningful work that makes apositive impact on a global scale. Join our colleagues in bringing ourMission to life – enabling our customers to make the world healthier,cleaner and safer. We provide our teams with the resources needed toachieve individual career goals while taking science a step beyond throughresearch, development and delivery of life-changing therapies. Withclinical trials conducted in 100+ countries and ongoing development ofnovel frameworks for clinical research through our PPD clinical researchportfolio, our work spans laboratory, digital and decentralized clinicaltrial services. Your determination to deliver quality and accuracy willimprove health outcomes that people and communities depend on – now andin the future.Location/Division Specific InformationThis role will be embedded within a client dedicated team. You will workalongside the clients own experienced personnel, as well as PPD colleaguesto deliver innovative clinical support.Discover Impactful Work:The Study Manager has global responsibility for one or more studies ofmoderate complexity generally with responsibility for all study managementaspects of assigned studiesProvides quality oversight to the Contract Research Organization (CRO) andof the CRO deliverables related to study execution.Leads and coordinates the execution of a clinical trial from Study start-upthrough Database close and inspection readiness to ensure timely deliveryof quality study data. Study Managers may also input to and supportcompilation of sections to Clinical Study Reports.Will provide leadership to the teams in the setting of realisticrecruitment targets and delivery milestones as the single point ofaccountability for detailed study start-up and monitoring plans and fordelivery to the agreed plans.Works with functional lines and directly with CRO line functions to resolveor triage site level issues.Will drive decision making and work closely with the Clinical ProjectManager to provide input to operational strategy.For studies where more than one Study Manager is assigned, may be requiredto act as 'lead' study manager, and will coordinate activities of theother Study Managers assigned.A day in the Life:Accountable for the development of realistic detailed study startup andmonitoring plans as well as study deliveryAccountable for conducting country level feasibility in collaboration withGlobal Clinical Trial Execution and CROs, reviewing Pre-trial Assessmentoutputs, approving sites, and assessing site activation plansLeads study risk planning process in context of site and subjectCoordinate study/protocol training & investigator meetingsDevelops and provides key inputs to Clinical Trial BudgetLeads inspection readiness activities related to study management and sitereadinessMay produce or review model Informed Consent Document (ICD) andstudy/country/site level ICD, as appropriateMay expand study design document into approved protocol template whileincorporating input from other team members (e.g., Clinician, ClinicalPharmacology Lead, Supply Chain Lead, Statistician, Outcomes ResearchRepresentative, Clinical Assay Group, etc.)Keys to Success:Education:MS/PhD – minimum of 3 years of proven experienceBS/Nurse – minimum of 5 years of proven experienceExtensive global clinical trial/study management experienceWorking knowledge of Good Clinical Practices, monitoring, clinical andregulatory operationsExperienceDemonstrated study management / leadership experienceDemonstrated oversight of CROsDemonstrated experience in managing Per Subject Costs, vendor &ancillary, and monitoring costs projections & spendKnowledge, Skills, AbilitiesUnderstands how to work with vendors to accomplish tasksAbility to interpret study level data & translate and identifyrisksAbility to proactively identify & mitigate risks around site level instudy executionUnderstands feasibility of protocol implementationCountry level cultural awareness and strong interpersonal skillsKeen problem-solving skillsExcellent communication skills, both written and verbal. Must be fluent inEnglish.Detail oriented & possesses technical expertise (e.g., spreadsheets,metrics & data flow management)Our Mission is to enable our customers to make the world healthier, cleanerand safer. Watch as our colleagues explain 5 reasons to work with us. Asone team of 100,000+ colleagues, we share a common set of values –Integrity, Intensity, Innovation and Involvement – working togetherto accelerate research, solve complex scientific challenges, drivetechnological innovation and support patients in need. #StartYourStory withPPD, part of Thermo Fisher Scientific, where diverse experiences,backgrounds and perspectives are valued.Apply today! http://jobs.thermofisher.comThermo Fisher Scientific is an EEO/Affirmative Action Employer and does notdiscriminate on the basis of race, color, religion, sex, sexualorientation, gender identity, national origin, protected veteran status,disability or any other legally protected status.Tagged as: remote, remote job, virtual, Virtual Job,virtual position, Work at Home, work from homeWhen applying state you found this job on Pangian.com Remote Network.#J-18808-Ljbffr
