Sr. Clinical Scientist

Vita Global Sciences, a Kelly Company; Rahway (NJ); Presencial; USD 90 000 - 150 000; Tempo integral

Resumo da oferta

Kelly Science and Clinical FSP in Rahway, NJ is seeking a Sr. Clinical Scientist for a long-term engagement. The role leads clinical execution of protocols and provides scientific input across data management, safety monitoring, and publications.

Eligible for full benefits and a comprehensive suite of wellness options. The candidate will act as clinical contact for scientific issues, design trials, lead the MM team, and collaborate on governance, CSRs, and publications.

Qualificações

• Minimum 2 years pharmaceutical and/or clinical drug development experience as a lead Clinical Scientist.
• Medical monitoring experience required.
• Excellent Excel and PowerPoint skills required.
• Excellent written and oral communication skills.

Responsabilidades

• Clinical point of contact for scientific issues 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 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.
• Collaborates with medical writing to develop trial results communication for investigators.
• Supports publications/presentations as needed.
• Reconciles and review all protocol deviation classifications in SPECTRUM.
• Assesses and prepares protocol deviation list for CSR.
• Act as mentor to other Clinical Scientists.

Conhecimentos

Excel

PowerPoint

Communication

Formação académica

Life Sciences degree

Ferramentas

SPECTRUM

Descrição da oferta de emprego

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, Vision, 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.