Senior Immunology Clinical Trial Lead (Remote)

Fortrea

United States

Remote

USD 135,000 - 150,000

Full time

14 days+

Get a reply from this employer

Your resume and cover letter, tailored to exactly what they’re hiring for.

Get past ATS filters

Job summary

Fortrea is seeking a Senior Clinical Scientist, FSP–Immunology to lead or support Phase 1–3 trials and assume medical monitoring responsibility. This is not a laboratory or research scientist role; you will drive clinical execution of protocols and serve as the scientific lead for the Clinical Trial Team. You will coordinate with CD, medical writing, data management, and IRB/site stakeholders.

Remote work options available in the US or Canada.

Qualifications

Degree in Life Sciences or significant experience in clinical development (>14 years).
BS/BA with 7+ years clinical research experience.
MS/PhD with 5+ years clinical research experience.
Minimum 2 years pharmaceutical and clinical drug development experience as a lead.
Proven ability to effectively manage multiple complex studies.
Medical monitoring experience is required.
TA-specific experience in Immunology.
Excellent Excel and PowerPoint skills.

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)
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