FSP Sr. Clinical Scientist - Immunology

Fortrea; United States; À distance; USD 135 000 - 150 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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

Connaissances

Medical Monitoring

Clinical Trial Design

Immunology

Excel

PowerPoint

Communication

Formation

Life Sciences degree

BS/BA in Life Sciences

MS/PhD in Life Sciences

Outils

Excel

PowerPoint

Description du poste

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 scientistrole . ***

In this role, the selected candidatewilllead/support studies;be accountable for the clinical/scientific execution of theprotocol; bethe 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 forinvestigators
• Leads the Medical Monitoring (MM) team in performing MM activities, including development of the Medical Monitoring Plan (MMP) and review of SAE reports, monitoring dataissuesand central labreports
• 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,participatesin governance committee review; authors protocol clarification letters; reconciles and reviews all protocol deviation classifications and assess and prepares protocol deviation list for theCSR
• May act as mentor to other Clinical Scientists

Requirements

Education

• Degree in Life Sciences orsignificant experiencein clinical development (>14 years)
• BS/BA with 7+yrsclinical research experience
• MS/PhD with 5+ years clinical research experience

Experience

• Minimum 2yearspharmaceutical and clinical drug development experience in a Clinical Scientist role as a leadrequired.
• Proven ability to effectively manage multiple complexstudies
• Medical monitoring experiencerequired
• TA-specific experience inImmunology
• Excellent Excel and PP skillsrequired
• 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.