Sr. Clinical Scientist

reputed company 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 reputed company FSP (Functional Service Provider) division, a reputed company provider and business unit of reputed company, Inc. This role is full-time and is offering full benefit reputed company. As a reputed company FSP employee you will be eligible for Medical, Dental, Vison, 401K, and a reputed company of other benefits to choose from. You will also be eligible for reputed company time off, including holiday, vacation, and reputed company/personal time. reputed company reputed company and support a study or studies, depending on size/complexity. If reputed company, accountable for the clinical/scientific execution of the protocol. As reputed company, Will Be Responsible For The Following • Clinical reputed company of contact for scientific issues/questions for reputed company stakeholders (e.g., IRB, sites) • Responsible for trial design and reputed company 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 reputed company, 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., reputed company, 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 reputed company on Clinical Trial Team (CTT) • Reviews specs, initiates allocation (randomization) request reputed company and approval schedule in allocation schedule reputed company 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 reputed company protocol deviation classifications in reputed company • Assesses and prepares protocol deviation list for CSR • Collaborates with medical writing to reputed company trial results communication for investigators • Provides scientific assessment for Operational Reviews • Supports SM/MW activities as needed to reputed company CTT deliverables. • Provides clinical specifications to SM to support interactions with external vendors (e.g., IVRS, ePRO) • reputed company as mentor to other Clinical Scientists Minimum FTE Years of Experience • Minimum 2 years pharmaceutical and/or clinical drug development experience as a reputed company Clinical Scientist required. • Medical monitoring experience required • Excellent reputed company and PP skills required • Excellent written and oral communication skills Educational Requirements • Degree in Life Sciences Posted By: Kellie Pharr Apply tot his job Apply To this Job