FSP Sr. Clinical Scientist - Immunology

Fortrea; Durham (NC); On-site; USD 135,000 - 150,000; Full time

Job summary

Fortrea is seeking a Senior Clinical Scientist for the FSP-Immunology program. Remote US or Canada. This role leads Phase 1-3 clinical trials and oversees medical monitoring, acting as the scientific lead on the Clinical Trial Team and as the clinical point of contact for internal and external stakeholders.

You will design trials with CD collaboration, manage medical monitoring plans, review SAE data and lab reports, participate in governance, and mentor junior scientists as needed.

Qualifications

• 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.
• Minimum 2 years pharma and clinical drug development experience in a Clinical Scientist role as a lead.

Responsibilities

• Lead/support studies; be accountable for clinical/scientific execution of the protocol.
• Medical monitoring leadership, including MMP and SAE data review.
• Provide scientific input to SM for data management activities (e.g., EDC, DRP, CRFs).
• Collaborate on protocols/amendments; participate in governance reviews and letters.
• Mentor to other Clinical Scientists when needed.

Skills

Clinical development

Immunology

Medical monitoring

Excel

PowerPoint

Communication skills

Education

BS/BA in Life Sciences

MS/PhD in Life Sciences

14+ years clinical development experience

Tools

EDC systems

Medical monitoring platforms

Job description

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 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 writ ing, 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.

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