Clinical Scientist

About the role

As a Clinical Scientist, you will play a pivotal role in fostering key relationships internally with clinical project teams and other study stakeholders. You will review scientific data, develop product knowledge, and communicate relevant information for one or more clinical studies.

Responsibilities

• Review scientific data and develop product knowledge to communicate relevant information for clinical studies.
• Develop and review study protocols, ensuring high-quality final documents.
• Prepare and present reports and presentations on clinical research findings.
• Regularly review information to verify safety procedures, efficiency, and data accuracy.
• Review and validate clinical study reports (CSRs) with a thorough understanding of the data connection.
• Contribute to, coordinate, and review regulatory documents, Consent Forms (ICF), and other study materials.
• Collaborate with study team members including Clinical/Medical Affairs, Clinical Operations, Drug Safety, Regulatory Affairs, and external vendors.
• Meet deadlines and milestones based on assigned study goals.
• Participate in protocol design, writing, and implementation to meet GCP, ICH, and regulatory requirements.
• Provide input into the drug development and evidence generation process as a technical expert.
• Conduct data review, which comprises 80% of the role.

Requirements

• 5 years of data review experience, with 3+ years in oncology.
• Experience with TFL Review, Medical Safety Data Review, and Results evaluation/review.
• Master's degree or higher in a related field.
• Proficient knowledge and skills to support program-specific data review, trend identification, and data interpretation.
• Proficient in Medical Terminology and medical writing skills.
• Knowledge of ICH, GCP, and other regulatory guidelines.
• Ability to analyze clinical information efficiently with strong written communication skills.
• Strong communication, presentation, analytic, and strategic capabilities.
• Ability to collaborate effectively with medical experts and cross-functional teams.

Qualifications

• Completion of PharmD, PhD, MD, MS, PA, NP, or equivalent education and experience.
• Experience in oncology and solid tumors is required.

Work Environment

This role is entirely remote, with no travel required.

Pay

The pay range for this position is $90.00 - $95.00/hr.

Benefits

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)