FSP Sr. Clinical Scientist - Immunology

Fortrea • Durham, NC

3d • Remote

About The Position

This role leads Phase 1-3 Clinical Trials and oversees medical monitoring. This is not a laboratory/research scientist role. In this role, the selected candidate will lead/support studies; be accountable for the clinical/scientific execution of the protocol; be the clinical point of contact for scientific issues/questions for internal and external stakeholders (e.g., IRB, sites); and act as scientific lead on the Clinical Trial Team (CTT).

Requirements

• BS/BA with 7+ yrs clinical research experience
• MS/PhD with 5+ years clinical research experience
• Minimum 2 years pharmaceutical and clinical drug development experience in a Clinical Scientist role as a lead
• Proven ability to effectively manage multiple complex studies
• Medical monitoring experience
• TA-specific experience in Immunology
• Excellent Excel and PP skills
• Excellent written and oral communication skills

Nice To Haves

• Degree in Life Sciences or significant experience in clinical development (>14 years)

Responsibilities

• Responsible for trial design and endpoint development in collaboration with CD
• Collaborates with medical writing to develop trial results communication for investigators
• Leads the Medical Monitoring (MM) team in performing MM activities, including development of the Medical Monitoring Plan (MMP) and review of SAE reports, monitoring data issues and central lab reports
• Sets up/supports SAC, DMC, adjudication committee
• Provides scientific input to SM for data management activities (e.g. EDC, DRP, CRF’s)
• Authors protocol clarification letters
• Reconciles and reviews all protocol deviation classifications and assess and prepares protocol deviation list for the CSR
• May act as mentor to other Clinical Scientists

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Associate degree