Clinical Scientist (Remote - US)

Responsibilities:

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

• Review the scientific data and develop product knowledge to understand and communicate the 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 the reports and presentations on the various findings of the clinical research

• Regularly review the information to check safety procedures, efficiency, and the lab data 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 upon 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 be data review

Additional Skills & Qualifications:

• Completion of PharmD, PhD, MD, MS, PA, NP, or equivalent education and experience

• Experience in oncology and solid tumors

• Phase 1/early phase experience

• Must have 5 years of data review experience, 3+ within oncology

• Proficiency in study design, con med, and lab review

• Proficient knowledge and skills to support program-specific data review, trend identification, and data interpretation

• Proficiency in medical terminology and medical writing skills

• Knowledge of ICH, GCP, and other relevant regulatory guidelines

• Proven ability to analyze clinical information succinctly and efficiently

• Strong written communication skills, especially in developing clinical protocols, assessing data quality, and presenting trial results

• Strong communication, presentation, analytic, and strategic capabilities

• Ability to effectively collaborate with medical experts

• Ability to collaborate with all levels of management in a cross-functional team environment

Pay and Benefits

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

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)

Workplace Type

This is a fully remote position.

Application Deadline

This position is anticipated to close on Mar 21, 2025.

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:

• Hiring diverse talent

• 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 actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.