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, Vison, 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
Posted By: Kellie Pharr