Job Summary
- Company
- BioSante Pharmaceuticals, Inc.
- Location
- Lincolnshire, IL 60069
- Industries
- Biotechnology/Pharmaceuticals
- Job Type
- Full Time
- Employee
- Years of Experience
- 2+ to 5 Years
- Education Level
- Bachelor's Degree
- Career Level
- Experienced (Non-Manager)
Clinical Project Manager / Senior Clinical Research Associate
About the Job
BioSante Pharmaceuticals is a specialty pharmaceutical company, located in Lincolnshire, IL, focused on developing products for female sexual health, menopause, contraception and male hypogonadism. This is an excellent opportunity for high visibility and ability to impact the business in a fast-paced environment.
This position provides a rewarding opportunity for an experienced Senior Clinical Research Associate or Clinical Project Manager to apply his/her established skills. This position is responsible for conducting clinical studies in accordance with GCPs, SOPs, FDA and ICH regulations including protocol development, CRF design, site source documents, and site training materials. Work with senior management to ensure appropriate collection of the primary study data and may prepare and negotiate investigator contracts and budgets and manage site activities and CRO activities. Ensure quality site selection, thorough site training, and appropriate site monitoring. Participate in establishing and managing processes to track critical study information such as: enrollment, regulatory documents, appropriate training of site personnel, protocol violations, and appropriate collection of the primary study data. Serve as the primary contact for assigned sites and document all site questions and issues for the purpose of discussing with senior management to ensure appropriate resolution of all site questions and issues.
This position provides a rewarding opportunity for an experienced Senior Clinical Research Associate or Clinical Project Manager to apply his/her established skills. This position is responsible for conducting clinical studies in accordance with GCPs, SOPs, FDA and ICH regulations including protocol development, CRF design, site source documents, and site training materials. Work with senior management to ensure appropriate collection of the primary study data and may prepare and negotiate investigator contracts and budgets and manage site activities and CRO activities. Ensure quality site selection, thorough site training, and appropriate site monitoring. Participate in establishing and managing processes to track critical study information such as: enrollment, regulatory documents, appropriate training of site personnel, protocol violations, and appropriate collection of the primary study data. Serve as the primary contact for assigned sites and document all site questions and issues for the purpose of discussing with senior management to ensure appropriate resolution of all site questions and issues.
Requirements:
Bachelors or Masters degree in a scientific field with a minimum of 3 years experience for a Sr CRA or 5 years experience for a CPM executing clinical trials in a pharmaceutical company.
· Track record of successful clinical trial completion in terms of time, quality standards and budget.
· Practical experience in protocol development (study design) and a good understanding of CRA skills (such as site identification, monitoring, enrollment racking and data collection/data management).
· Good knowledge of GCPs and FDA regulatory requirements and ability to assess compliance required.
· Project and time management skills required.
· Good understanding of drug development and clinical trial methodology.IND and NDA submission experience is preferred.
· Hormone replacement, endocrinology experience a plus.
· Regulatory affairs experience a plus.
Company Tools
Contact Information
BioSante Pharmaceuticals, Inc.
Lincolnshire, IL
