Sr. Clinical Scientist

Kelly Science and Clinical FSP is currently seeking a Sr. Clinical Scientist for a long-term engagement with one of our Global Pharmaceutical clients. This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly Services, Inc. This role is full-time and is offering full benefit options. As a Kelly FSP employee you will be eligible for Medical, Dental, Vision, 401K, and a variety of other benefits to choose from. You will also be eligible for paid time off, including holiday, vacation, and sick/personal time. Summary Lead and 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 system Coordinates 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 publications/presentations as needed Reconciles and review all protocol deviation classifications in SPECTRUM Assesses and prepares protocol deviation list for CSR Collaborates with medical writing to develop trial results communication for investigators Provides scientific assessment for Operational Reviews Supports SM/MW activities as needed to achieve CTT deliverables. Provides clinical specifications to SM to support interactions with external vendors (e.g., IVRS, ePRO) Act as mentor to other Clinical Scientists Minimum FTE Years of Experience Minimum 2 years pharmaceutical and/or clinical drug development experience as a lead Clinical Scientist required. Medical monitoring experience required. Excellent Excel and PP skills required. Excellent written and oral communication skills. Educational Requirements Degree in Life Sciences. #J-18808-Ljbffr Vita Global Sciences, a Kelly Company