Brazil - Senior Clinical Scientist Consultant

1 dia atrás

Brasília, Brasil Clinchoice Tempo inteiro

Senior Clinical Scientist I(Clinical Research/Clin Ops)Description of ServicesMay lead or support a study or studies, depending on size/complexity.If lead, accountable for the clinical/scientific execution of the protocol.As lead, will be responsible for the following:Clinical point of contact for scientific issues/questions for internal and external stakeholders (e.g., IRB, sites)Responsible for trial design and endpoint development in collaboration with CDLeads the Medical Monitoring (MM) team in performing MM activities, including development of the Medical Monitoring Plan (MMP) and review of SAE reportsSets up/supports SAC, DMC, adjudication committeesProtocols/amendments – collaborates with medical writer, participates in governance committee reviewAuthors protocol clarification lettersContributor to study specific documents (e.g., SMP)Reviews/updates informed consentProvides scientific input to SM for data management activities (e.g., EDC, DRP, CRFs)Monitors data issues requiring clinical inputMonitors central lab reports and other external data for safety and critical valuesPrepares scientific slides, attends and presents protocol information at Investigator MeetingScientific lead on Clinical Trial Team (CTT)Reviews specs, initiates allocation (randomization) request form and approval schedule in allocation schedule generation systemCoordinates planning of lab, bio specimens and imaging specificationsCo- authors newsletters with SMParticipates in Database lock activitiesCollaboratively plans CSRs, CTDs/WMAs with medical writingSupports publications/presentations as neededReconciles and review all protocol deviation classifications in SPECTRUMAssesses and prepares protocol deviation list for CSRCollaborates with medical writing to develop trial results communication for investigatorsProvides scientific assessment for Operational ReviewsSupports SM/MW activities as needed to achieve CTT deliverables.Provides clinical specifications to SM to support interactions with external vendors (e.g., IVRS, ePRO)May act as mentor to other CSsMinimum Years of ExperienceMinimum 7 years for BS/BA or 5 years for MS/PhD pharmaceutical and/or clinical drug development (such as pharmaceutical/biopharma companies, hospital settings, research sites, clinical trial units, CRO, SMO) in the last 10 years required experience Minimum 2 years as a lead CS (phase I-IV clinical trials) with pharmaceutical/bio-tech/CRO company experience required (leads, monitors and supervises the tasks related to clinical trials) in the last 5 years.TA-specific experience required for Oncology.TA specific experience preferred for IDV and GSMIndication specific experience preferredExperience reviewing and resolving study related data issues such as; issued queries, resolved queries, accurate review of medical records, identify any errors in data by performing data review that require further clarification with the study sites, etc. required2 years medical monitoring (proficient in reviewing patient data and resolving discrepancies in the following areas such as adverse events, trends of adverse events, end point management, labs) experience requiredDemonstrated oral and written communication skillsProficiency in Microsoft Office (Outlook, Word, Excel and PowerPoint) required.One Note experience preferred.Motivate their team, handle and delegate responsibilities, listen to feedback and remain flexible.Educational RequirementsDegree in Life SciencesBS/BA/MS/PhD

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