Clinical Research Scientist

Job Description

Job Ttitle: Clinical Research Scientist

Company: Actalent


Description: Job Title: Clinical ScientistJob DescriptionAs a Clinical Scientist, you will maintain key relationships 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. Your role includes developing and reviewing study protocols, preparing and presenting reports, and regularly checking safety procedures, efficiency, and lab data accuracy. You will also validate clinical study reports, contribute to regulatory documents, and collaborate with various team members to meet study goals.Responsibilities

• Review scientific data and develop product knowledge for clinical studies.
• Develop and review study protocols with minimal guidance.
• Prepare and present reports and presentations on clinical research findings.
• Regularly review information to check safety procedures, efficiency, and lab data accuracy.
• Review and validate clinical study reports (CSRs).
• Contribute to, coordinate, and review regulatory documents 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.

Essential Skills

• 5+ years of data review experience.
• 3+ years of data review experience in oncology and phase 1 clinical trials.
• Must have Phase I/Early Phase experience (ideally in oncology)
• Solid Tumor experience is required
• EDC experience
• Study design experience (how to enroll subjects into cohorts), con med and lab review is required.
• Completed Masters degree or higher (PharmD, PhD, MD, MS, PA, NP, or equivalent).
• Proficient knowledge and skills in 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 effectively collaborate with medical experts and cross-functional teams.

Additional Skills & Qualifications

• Phase 1 / Early Phase Experience.
• Solid Tumor Experience.
• Study Design experience.

Work EnvironmentThis is a remote role with no travel required. The company provides an outstanding training program for new consultants, including a mentorship program and strong corporate leadership.Pay and BenefitsThe pay range for this position is $90.00 – $95.00

• 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 TypeThis is a fully remote position.Application DeadlineThis position will be accepting applications until Dec 27, 2024.About ActalentActalent 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 & InclusionAt 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 for other accommodation options.

Salary:

Location: New Jersey

Date: Thu, 19 Dec 2024 08:40:25 GMT


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