Associate Project Manager II at Thermo Fisher Scientific

Work ScheduleFirst Shift (Days)Environmental ConditionsSome degree of PPE (Personal Protective Equipment) required (safety glasses gowning gloves lab coat ear plugs etc.)Job DescriptionManages all aspects of assigned clinical trials involving patient and healthy subject populations in bothinpatient and outpatient settings. Acts as liaison between the Sponsor the Investigator and the researchteam. Ensures client requirements and specifications are communicated to the research teams and anyissues/questions raised by the research team or investigators are communicated back to the client forresolution.Essential Functions and Other Job Information: Serves as a primary point of contact for sponsors and the business unit forclinical site related aspects of the study. Collaborates with internal departments to ensure deliverables are met as definedwithin the contract and study timeline. Manages all clinical and administrative aspects of a clinical project including site level study set-up recruitment conduction and data collection. Manages IRB submissions. including creation of study specific informed consentforms SAE notifications and maintenance of the regulatory file and documents. Collects feedback from various departments to create a risk register for eachstudy and maintains and updates the register throughout the study; works withthe Principal Investigator to ensure that a risk mitigation plan (RMP) is finalizedand reviewed by the safety committee prior to study conduct. Works closely with finance department to manage fiscal aspects of study conductwhile meeting sponsor requirements and adhering to the protocol SOPs andcontract. Provides vendor oversight when services are contracted.Qualifications:Education and Experience:Bachelors degree or equivalent and relevant formal academic / vocational qualificationPrevious experience that provides the knowledge skills and abilities to perform the job (comparable to2 years).In some cases an equivalency consisting of a combination of appropriate education trainingand/or directly related experience will be considered sufficient for an individual to meet therequirements of the role.Knowledge Skills and Abilities: Knowledge of Phase I processes and strong knowledge of clinical study operations Knowledge of FDA regulations and ICH GCP guidelines Knowledge of budgeting/forecasting/planning projects Solid computer skills with working knowledge of Microsoft Office applications Good time management and multi-tasking skills Excellent written and verbal communication skills Demonstrated ability to prioritize workload and adapt to changing study needs Demonstrated ability to act as a liaison between external and internal groupsManagement Role:No management responsibilityRequired Experience:IC Key Skills Bluebeam,Construction Estimating,Construction Experience,ProCore,Microsoft Outlook,Prolog,Construction Management,Project Engineering,Project Management,Project Management Software,Microsoft Project,Budgeting Employment Type : Full-Time Experience: years Vacancy: 1