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Durham, North Carolina, United States
Remote only
Senior Clinical Scientist, FSP – Immunology – Remote US or Canada
***Position 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 Clinical Trial Team (CTT).
Responsibilities include:
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_
Protocols/amendments – collaborates with medical writing, participates in governance committee review; 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
Requirements:
Education:
Degree in Life Sciences or significant experience in clinical development (>14 years)
BS/BA with 7+ yrs clinical research experience
MS/PhD with 5+ years clinical research experience
Experience:
Minimum 2 years pharmaceutical and clinical drug development experience in a Clinical Scientist role as a lead required.
Proven ability to effectively manage multiple complex studies
Medical monitoring experience required
TA-specific experience in Immunology
Excellent Excel and PP skills required
Excellent written and oral communication skills
Target Pay Range for US: $135-150K
Physical Demands/Work Environment:
Work Environment:
Work is performed in an office environment with exposure to electrical office equipment.
Frequent travel to clients/ site locations with occasional travel both domestic and international.
Physical Requirements:
Ability to sit for extended periods and operate a vehicle safely.
Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.
Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
Regular and consistent attendance.
Varied hours may be required.
Learn more about our EEO & Accommodations request here.
