[Hiring] Senior Clinical Scientist @Fortrea

Role Description

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)
• 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
• Monitors 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)
• Collaborates with medical writing on protocols/amendments, participates in governance committee review
• Authors protocol clarification letters
• Reconciles and reviews all protocol deviation classifications and assesses and prepares protocol deviation list for the CSR
• May act as mentor to other Clinical Scientists

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

Requirements

• 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

Benefits

• 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.