Sr. Clinical Scientist

Vita Global Sciences, a Kelly Company; Rahway (NJ); On-site; USD 90,000 - 150,000; Full time

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Excel

PowerPoint

Communication

Education

Life Sciences degree

Tools

SPECTRUM

Job description

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.