Clinical Scientist

Catalyst Clinical Research • Raleigh, NC

386d

About The Position

As a Clinical Scientist, you will play a crucial role in the Clinical Development Operations, specifically within the Clinical Science Team. Your primary responsibility will be to review and assess clinical data before it undergoes Medical/Client review, ensuring the integrity of the clinical database and regulatory projects. You will communicate findings to the Study Team and Client, collaborating closely to meet project timelines and expectations. This position requires a proactive approach to improve collaboration and efficiency in data-related deliverables, while also mentoring and training staff as needed.

Requirements

• Advanced clinical/science degree (e.g., PharmD, PhD, MSN, MPH) preferred.
• 5 or more years of industry/related experience OR Bachelor's degree in a life-science or nursing with 10 years or more of industry/related experience.
• Extensive knowledge of the clinical development process and study design principles.
• Comprehensive understanding of product and safety profiles.
• Experience in data analysis, interpretation, and clinical relevance.
• Familiarity with electronic data capture systems and data visualization tools.
• Well-versed in GCP, ICH, and relevant regulatory requirements.
• Proficient with Microsoft Office Suite.
• Excellent written and oral communication skills.
• Strong organizational, problem-solving, and analytical skills.
• Ability to manage priorities and workflow effectively.
• Versatility and flexibility in adapting to changing priorities.
• Proven ability to handle multiple projects and meet deadlines.
• Strong interpersonal skills and ability to work with diverse individuals.
• Commitment to excellence and high standards.
• Creative, flexible, and innovative team player.
• Ability to work independently and collaboratively in teams.
• Good judgement and decision-making skills.
• Willingness to travel to meetings or Client sites.

Nice To Haves

• Experience with Visual Analytics interpretation.

Responsibilities

• Partner with the Study Team in the development of data review plans for individual clinical studies.
• Collaborate with appropriate Study Team members to ensure protocol-defined variables are reported and collected appropriately.
• Communicate and present pertinent trends/findings of clinical research to the Project Medical Monitor, Study Team, and Client.
• Participate in tracking and analysis of potential safety events within trials.
• Review safety and efficacy data for trends and clinical soundness.
• Contribute to the review and analysis of safety information with Pharmacovigilance and Medical Monitor.
• Engage in discussions regarding modifications in study strategy based on data review.
• Collaborate with Study Team members and third-party vendors to ensure proper reporting and collection of protocol endpoints.
• Assist in developing study-specific listings and conduct ongoing clinical data listing reviews.
• Serve as primary point of contact for clinical study inquiries from site staff and monitors.
• Partner with Data Management for CRF design and data quality review plan.
• Review and provide input to data-driven sections of reporting documents.
• Assist in the preparation of key documents for regulatory submissions.
• Mentor and/or train staff as needed.
• Provide scientific writing for projects such as narratives or non-regulatory documents.

What This Job Offers

• Job Type: Full-time
• Industry: Administrative and Support Services
• Education Level: Bachelor's degree