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, Vison, 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 Posted By: Kellie Pharr Apply tot his job