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

Job Overview:Senior Clinical Scientist - OncologyClinical Trial Mgmt and Medical Monitoring experience is requiredRemote in the USA or CanadaWhy settle for one thing when you can have everything? Covance by Labcorp gives you the best two-for-one opportunity for career growth. Who doesn't want twice the perks? Working at Covance-one of the largest FSP CROs-and partnering with one sponsor with a dedicated therapeutic focus. You can have it all!Dedicated to an FSP project, 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 pharmacovigilance, we have an FSP opportunity to match your area of expertise.You will enjoy the best of both worlds-all the benefits that come along with our 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.Our 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.Our reach is global - extending to 60+ countries making us one of the largest FSP CROs. No matter where you are located on the globe, we have an FSP opportunity for you.In 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. 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 CD Leads the Medical Monitoring (MM) team in performing MM activities, including development of the Medical Monitoring Plan (MMP) and review of SAE reports Sets up/supports SAC, DMC, adjudication committees Protocols/amendments - collaborates with medical writer, participates in governance committee review Authors protocol clarification letters Contributor to study specific documents (e.g., SMP) Reviews/updates informed consent Provides scientific input to SM for data management activities (e.g., EDC, DRP, CRFs) Monitors data issues requiring clinical input Monitors central lab reports and other external data for safety and critical values Prepares scientific slides, attends and presents protocol information at Investigator Meeting Scientific 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 specifications Co- authors newsletters with SM Participates in Database lock activities Collaboratively plans CSRs, CTDs/WMAs with medical writing Supports publicationsresentations as needed Reconciles and review all pr

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