Clinical Scientist

Actalent; Alameda (CA); Remote; USD 80,000 - 120,000; Full time

Job summary

An established industry player is seeking a Clinical Scientist to join their remote team. This role focuses on data review and developing study protocols, ensuring high-quality documentation and compliance with regulatory standards. You will collaborate with various stakeholders, including Clinical Operations and Drug Safety, to contribute to the success of clinical studies. This opportunity offers a chance to make a significant impact in the field of oncology research while working in a supportive and inclusive environment. If you are passionate about advancing clinical science and thrive in a remote setting, this position is perfect for you.

Qualifications

• 5+ years of experience in data review, particularly in oncology.
• Master's degree or higher required for this role.

Responsibilities

• Review scientific data and develop product knowledge for clinical studies.
• Prepare and present reports on clinical research findings.
• Collaborate with study team members and ensure regulatory compliance.

Skills

Data Review

Oncology Data Review

TFL Review

Medical Safety Data Review

Clinical Protocol Development

Education

Master's Degree

Job description

You will have key relationships internally with the clinical project (study) team and other study stakeholders.

Review scientific data and develop product knowledge to understand and communicate relevant information for one or more clinical studies.

Develop and review various study protocols with minimal guidance, including writing, reviewing, adjudication / resolution of cross-functional comments, and ensuring a high-quality final document.

Prepare and present reports and presentations on the findings of clinical research.

Regularly review information to check safety procedures, efficiency, and the lab data's accuracy and correctness.

Review and validate clinical study reports (CSRs) with a thorough understanding of the connection between the data and the CSR.

Contribute to, coordinate, and review regulatory documents, Consent Forms (ICF), and other relevant study materials.

Collaborate with all study team members including Clinical / Medical Affairs, Clinical Operations, Drug Safety, Regulatory Affairs, and external vendors.

Meet deadlines and milestones required based on assigned study goals.

May be asked to participate in protocol design, writing, and implementation to meet GCP, ICH, and regulatory requirements.

May be asked to provide input into the drug development and evidence generation process as a technical expert.

80% of the role will involve data review.

Hard Skills

• 5 years of data review
• 3+ years of data review in oncology
• Experience with TFL Review
• Medical Safety Data Review
• Completed Master's degree or higher

Work Site

This is a fully remote position.

Remote role / No travel

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through :

• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email [emailprotected] (%[emailprotected] ) for other accommodation options.

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Clinical Scientist • Alameda, CA, United States