Note: The job is a remote job and is open to candidates in USA. Kelly Science and Clinical FSP provides managed functional service solutions for pharmaceutical clients and is seeking a Senior Clinical Scientist for a long-term engagement. The role leads or supports clinical studies, overseeing scientific execution, trial design, medical monitoring, protocol development, data review, regulatory documentation, and mentorship of other Clinical Scientists.

Responsibilities

• 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

Skills

• 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
• Degree in Life Sciences

Benefits

• Full benefit options
• Medical, Dental, Vison, 401K
• Paid time off, including holiday, vacation, and sick/personal time

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