Kelly Science, Engineering, Technology & Telecom · 1 day ago
Senior Clinical Research Scientist
United States
Full-time
Remote
Mid, Senior Level
2+ years expKelly Science, Engineering, Technology & Telecom is seeking a Senior Clinical Research Scientist to lead and support clinical studies. The role involves being the clinical point of contact for scientific issues, overseeing trial design, and leading medical monitoring activities among other responsibilities.
Staffing & Recruiting
Hiring Manager
Kellie Pharr
Responsibilities
Lead and support a study or studies, depending on size/complexity. If lead, accountable for the clinical/scientific execution of the protocol
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
Qualification
Required
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
Company
Kelly Science, Engineering, Technology & Telecom
Kelly Science, Engineering, Technology & Telecom specializes in science, engineering, technology, and telecom.
5001-10000 employees
Funding
Current Stage
Late StageLeadership Team
Linda Stuit
Senior Vice President, Engineering Specialty
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