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For more than 90 years, Standard Process Inc. has been a visionary leader in whole food nutrient solutions. Our whole food philosophy and mission to change lives extends far beyond our supplements to the very people we employ. This strong foundation has created an environment where our employees are seen as members of our family and are given the tools and resources to succeed, both personally and professionally.
The Manager of Clinical Research oversees Clinical Development processes/operations, implementation of relevant SOPs, protocol design for clinical trials in collaboration with internal/external stake holders, sourcing of work, and data management.
Hours: 8:00am - 4:30pm (EDT) , Monday-Friday, or as job responsibilities require
- Manage the clinical development processes, procedures, lab capabilities
- Contribute and manage the clinical research lab infrastructure and operations to maintain an organized and safe work environment. Assist and/or train others when appropriate.
- Provide scientific leadership in execution of clinical trials in compliance with ICH/GCP guidelines, generating clinically/scientifically sound data to confirm performance claims supporting regulatory submissions, and to ensure that the product conforms to defined user needs and/or requirements.
- Work closely with cross-functional team within the organization, implement, and complete clinical studies, generation of study-related documents and/or contribute content and oversight of such documents, including, but not limited to, clinical study protocols, case report forms, clinical study reports, and informed consent forms.
- Oversee timely coordination of all activities including, protocol design, IRB approval, statistical analysis design, securing clinical software system for monitoring AE/SAE and MedDRA coding, data collection, data analysis, and data reporting.
- Serve as an active member of study teams and provide scientific support to justify trial design, ongoing scientific analysis during protocol development and resource to address questions or clarify potential issues during the conduct of the study.
- Manage and support Clinical Research Scientists and Clinical Study Coordinators
- Develop strategies and provide clinical guidance on submissions for, and interfaces with applicable US regulatory authorities.
- Develop innovative approaches for both external and internal projects and contribute to the optimization of internal processes and workflows to support the business needs of the organization.
- Partner with Discovery, Product Development, Regulatory and Quality Assurance leveraging strategic research to ensure claims are feasible and can be validated by clinical trials.
- PhD in Nutrition or Life Sciences, Medical Biochemistry, or equivalent field (or Master’s with significant experience)
- Clinical Fellowship in any functional health science area preferred
- 5-10 years of experience in Clinical Research and Nutrition Science
- 5+ years of organizational management
- Experience using advanced clinical research tools for targeted health outcome
- Experience managing team of scientists performing research, , clinical trial coordinators/monitors, safety scientists
- Experience in handling laboratory instruments, assay development, automated and analytical devices
Specialized Knowledge and Skills:
- Knowledge of clinical science, preclinical research, product safety/quality and regulatory compliance, manufacturing operations, audits, supply chain
- Demonstrate skills in managing clinical research team, project management, effective communication and problem solving, good networking, influencing, develop SOPs for process improvements, documentation, affiliate training, initiate external engagement and collaborations with academic institutions and industries on the possible business relevant strategies and outcomes
- Works collaboratively to develop solutions and provide guidance to others in analyzing and solving problems
- Engages in discussion to promote developmental insight and planning, offers to share own experience and expertise
- Adjusts with ease and manage competing demands
- Establishes structures and processes to manage change and communicate change effectively, closely monitor transition, evaluate result, and build commitment
- Identifies sources of conflicts and methods of management and choose appropriate techniques to solve issues
- Commits to complete tasks timely to accomplish goals, and take ownership for actions
- Recognizes and value the diversity/uniqueness of others to optimize individual’s contributions
- Makes decisions and conduct with organizational principles, and follow procedures
- Learns and adapts quickly in changing environments for successful performance.
Standard Process is proud to be a top workplace. We offer a comprehensive and competitive benefit package, which includes:
- Competitive salary and annual incentive program
- Comprehensive health care and flexible benefit plan, including pet insurance
- Company-matched 401(k) plan
- Profit sharing plan
- On-site childcare with highly accredited curriculum
- Platinum WELCOA award-winning wellness program, including:
- On-site 24x7 fitness center
- Whole food court
- On-site chiropractic care
- On-site massage therapist
- Personal trainer
- Daily fitness classes
- On-site life coach
- $450 monthly Standard Process supplement allowance
- Annual wellness incentives
- Paid vacation and holiday time
- Educational assistance
- Company hosted outings and events
- Strong community involvement
Apply today and become part of the Standard Process family!