**Clinical Program Manager**
**Kannapolis, NC**
Kelly Science and clinical is hiring for a Clinical Program Manager/ Sr Clinical Scientist to join our client who is a well known nutritional supplement company. This opportunity must be on site at least 3 days a week but will allow remote work from home 2 days a week once up and running and will reports to the Director of Clinical Nutrition and Education.
**Job Purpose:** Under the direction of the Director of Clinical Nutrition and Education, the Clinical Program Manager will be responsible for managing the day-to-day aspect of the clinical research team and work to develop studies based on the direction of the company.
+ Manage the companys clinical research, translating discovery science initiatives and support existing and new product portfolio.
+ Provide scientific guidance in analyzing clinical study data, clinical trial synopsis, preparation of clinical output summary reports, scientific presentations of the clinical data/insights at conferences, business meetings and related publications.
**Essential Functions:**
+ Oversee 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.
+ 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.
**Qualifications Education:**
+ PhD in Nutrition or Life Sciences, Medical Biochemistry, or equivalent field or Masters with significant experience
**Certifications/Licenses:** Clinical Fellowship in any functional health science area preferred
**Preferred Experience:**
+ 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 a team
\#P1
**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.
**Why Kelly** **** **Science & Clinical?**
Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the worlds most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goalsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.
**About Kelly** ****
At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.
Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kellys Human Resource Knowledge Center.
Kelly complies with the requirements of Californias state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.
Categories
• Biotechnology / Science
• Healthcare
• Information Systems
• Research Scientists
• Coordinators
• Monitoring
• Data Management