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Vita Global Sciences, a Kelly Company · 1 day ago

Sr. Clinical Scientist

Rahway, NJ

Contract

Onsite

Mid, Senior Level

2+ years exp

Vita Global Sciences, a Kelly Company, is currently seeking a Sr. Clinical Scientist for a long-term engagement with one of their Global Pharmaceutical clients. This role involves leading and supporting clinical studies, ensuring scientific execution of protocols, and collaborating with various stakeholders throughout the trial process.

AnalyticsData VisualizationInformation Technology

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

Qualification

Clinical trial designMedical monitoringPharmaceutical developmentData managementLife Sciences degreeExcel proficiencyPowerPoint proficiencyCommunicationMentoring