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Covance Senior Clinical Scientist / Medical Monitor Oncol in Detroit, Michigan

font class="bold"Job Overview:/fontspanspanSenior Clinical Scientist - Oncology/span/spanspanspanClinical Trial Mgmt and Medical Monitoring experience is required/span/spanspanRemote in the USA or Canada/span spanspanWhy settle for one thing when you can have everything/spanspan?/spanspan /span/span spanCovance gives you the best spantwo-for-one /spanopportunity for career growth. Who doesn't want twice the perksspan? W/spanorking at Covance-one of the largest FSP CROs-and partnering with one sponsor with a dedicated therapeutic focus. spanYou can have it all!/span/spanspanAs a Covance employee dedicated to an FSP projectspan,/span you will bring your specialized discipline to a core team working directly with one sponsor. Whether your specialization is in clinical monitoring, clinical project management, data management, biometrics or pharmacovigilancespan,/span Covance has an FSP opportunity to match your area of expertise./spanspanYou will enjoy the best of both worlds-all the benefits that come along with Covance's Energizing Purpose, Exceptional People and Extraordinary Potential combined with working exclusively with one sponsor and this also comes with the benefit of bringing your strong therapeutic experience to allow your expertise to shine through./spanspanCovance's FSP model is flexible and scalable. Our teams are collaborative and proactive - a great place for you to continue honing your therapeutic skills and growing and excelling in new and exciting research./spanspanCovance's reach is global - extending to 60+ countries making us one of the largest FSP CROs. No matter where you are locatspaned/span on the globe, we have an FSP opportunity for you./span spanIn this role, the selected candidate may lead or support a study or studies, depending on size/complexity. If lead, accountable for the clinical/scientific execution of the protocol./spanspan /spanspanAs lead, will be responsible for the following: /spanspan /spanullispanClinical point of contact for scientific issues/questions for internal and external stakeholders (e.g., IRB, sites) /span/lilispanResponsible for trial design and endpoint development in collaboration with CD /span/lilispanLeads the Medical Monitoring (MM) team in performing MM activities, including development of the Medical Monitoring Plan (MMP) and review of SAE reports /span/lilispanSets up/supports SAC, DMC, adjudication committees /span/lilispanProtocols/amendments - collaborates with medical writer, participates in governance committee review /span/lilispanAuthors protocol clarification letters /span/lilispanContributor to study specific documents (e.g., SMP) /span/lilispanReviews/updates informed consent /span/lilispanProvides scientific input to SM for data management activities (e.g., EDC, DRP, CRFs) /span/lilispanMonitors data issues requiring clinical input /span/lilispanMonitors central lab reports and other external data for safety and critical values /span/lilispanPrepares scientific slides, attends and presents protocol information at Investigator Meeting /span/lilispanScie