Principal Clinical Research Scientist
Company: Syneos Health
Location: Hybrid (Remote with travel as needed)
About Syneos Health
Syneos Health is a leading integrated biopharmaceutical solutions provider. By translating clinical, medical, and commercial insights into actionable outcomes, Syneos Health accelerates the development of therapies that meet the evolving needs of patients and the industry. The company prides itself on building diverse teams that innovate and help clients achieve their goals.
Why Join Syneos Health?
Career Development: Syneos Health supports career progression with ongoing training, mentorship, and a peer recognition program.
Inclusive Culture: The company values diversity, fostering an environment where all employees can bring their authentic selves to work.
Global Impact: With over 29,000 employees worldwide, Syneos is committed to accelerating the delivery of life-changing therapies.
Role Overview
The Principal Clinical Research Scientist will provide scientific and regulatory leadership for Early Phase clinical studies. This role involves working on complex study designs, protocols, regulatory submissions, and collaborating with internal teams to ensure high-quality clinical research outputs. It requires a deep understanding of clinical development, regulatory guidelines, and the drug development process.
Key Responsibilities
Scientific and Regulatory Leadership
Scientific Consulting: Provide scientific guidance and regulatory support to clients and internal teams for complex studies.
Study Design: Lead the planning and development of Early Phase study designs, protocols, and related documents. Ensure that study designs are both scientifically sound and prioritize subject safety.
Protocol Review: Participate in reviewing and providing input on protocols and project documents from clients and internal teams.
Regulatory Submissions: Prepare and submit clinical trial applications to regulatory agencies, ensuring compliance with all necessary regulations.
Project Leadership and Oversight
Scientific Leadership: Oversee scientific deliverables on assigned projects and ensure high-quality output across all stages of study conduct.
Document Management: Track and manage all study documents and deliverables, addressing issues as they arise.
Cross-functional Collaboration: Synthesize feedback from clients, stakeholders, ethics committees, and regulatory agencies into study documentation.
Client Relationship Management: Build and maintain strong relationships with clients to foster new business opportunities.
Team Development
Mentorship: Train, support, and mentor junior team members. Facilitate team training aligned with project and regulatory requirements.
Bid Defense Participation: Participate in bid defense meetings as needed to secure new business opportunities.
Qualifications
Required Experience & Skills
Master’s Degree (or equivalent) in Life Sciences or a related field.
Strong Regulatory Knowledge: Extensive knowledge of Good Clinical Practice (GCP), ICH guidelines, and the drug development process.
Experience: Previous experience in clinical research organizations (CROs) preferred.
Independent Work Style: Ability to manage time effectively and work independently.
Technology Proficiency: Skilled in Microsoft Word, Excel, PowerPoint, and Acrobat. Able to embrace new technologies in clinical research.
Communication Skills: Excellent communication skills, both written and spoken, with the ability to present and influence stakeholders effectively.
Mentorship: Ability to mentor junior staff and handle multiple tasks while delivering high-quality results in a fast-paced environment.
Compensation & Benefits
Syneos Health offers a comprehensive benefits package, including:
Salary Range: $85,500 - $175,700 annually (based on experience).
Additional Benefits: Health benefits (Medical, Dental, Vision), 401(k) with company match, employee stock purchase plan, performance-based bonuses, and flexible paid time off (PTO).
Other Perks: Company car or car allowance, commissions/bonus based on performance.
Apply Now to be part of an innovative team, making a real impact on the future of clinical research and therapies that change lives.
Syneos Health is an equal opportunity employer, committed to creating an inclusive environment where everyone feels they belong.
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