Sr. Clinical Scientist

Summary

Lead and support a study or studies, depending on size/complexity. If lead, accountable for the clinical/scientific execution of the protocol.

Responsibilities

• Responsible for the clinical/scientific execution of the protocol if lead.
• Point of contact for scientific issues/questions for internal and external stakeholders (e.g., IRB, sites).
• Leads the Medical Monitoring (MM) team in performing MM activities, including development of the Medical Monitoring Plan (MMP) and review of SAE reports.
• 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.
• 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 Meetings.
• 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, 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).
• Acts as mentor to other Clinical Scientists.

Requirements

• 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.

Qualifications

Minimum FTE

Skills

Not specified

Benefits

Full benefit options including Medical, Dental, Vision, 401K, and a variety of other benefits to choose from. Eligible for paid time off, including holiday, vacation, and sick/personal time.

Pay

TBD

Schedule

TBD