Steadman Philippon Research Institute
Listing Expires on 10/16/2020
The Clinical Trials Program Manager will be responsible for the planning, management, execution and completion of clinical trials in support of receiving federal and private sector grants and fulfilling grant related obligations.
Location: Vail, CO.
Classification: Full-time, exempt position with benefits
- Manage the planning and execution of clinical trials including the design and preparation of clinical trial protocols, study manuals, project-specific plan development, study timelines and other post-award activities.
- Manage collaboration with all principal investigators and other key clinical staff members to implement processes and structures for conducting clinical trials by institutional guidelines.
- Act as primary contact for sponsor representatives, vendors and third-party providers and collaborate on scope of work and project activities to ensure deliverables are completed on time and key performance indicators are monitored.
- Assures clear client and internal team communication, process documentation, and compliance with Good Clinical Practices (GCP) and procedures.
- Provide input and expertise for the development of clinical documents including protocols, case report forms, SOPs, investigator brochures, study manuals, study plans and IRB materials.
- Facilitate the development and management of study budgets.
- Anticipate complex study obstacles and implement solutions to achieve project goals.
- Monitor and manage clinical trial activities to ensure project goals and objectives are achieved and deliverables are on time and within budget.
- Prepare and review metrics and key performance indicators and provide suggestions that contribute to process improvements in support of departmental and organizational goals.
- Mentor and manage clinical trials junior staff.
- Follow policies and procedures established in the SPRI Employee Handbook; adhere to SPRI safety policies.
- Perform other duties as assigned.
- Bachelor of Science degree in a relevant science or medical discipline required. Master’s degree preferred.
- 5+ years of relevant experience in clinical trial management required, prefer experience working with the DoD, NIH and other government grant agencies.
- Active CRC (from ACRP) or CCRP (from SOCRA) accreditation preferred.
- Strong written and verbal communication, interpersonal, analytical and problem solving skills.
- Extensive knowledge of clinical study and drug development processes and GCP/ICH guidelines.
- Demonstrated understanding of medical regulatory requirements and impact on development of clinical trials.
- Experience with Microsoft Office Suite and metrics software.
- Successful experience in a fast-pace entrepreneurial non-profit environment.
- Knowledge basic orthopaedic terminology and human anatomy is preferred.
- Health Insurance (medical, dental, vision)
- Retirement Plan match up to 4%
- Four weeks of Paid Time Off (PTO) in year one
- Paid Holidays
- Life Insurance
- Short and Long Term Disability Insurance
- Referral Program Incentive
- Ski Pass Bonus
- Paid parking
- And more!
We are an Equal Opportunity Employer. We are committed to equal treatment of all employees without regard to race, national origin, religion, gender, age, sexual orientation, veteran status, physical or mental disability or other basis protected by law.