JOB SUMMARY: The Clinical Trial 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.
CLASSIFICATION: This is a 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.
Manage external resources as required.
May be responsible for mentoring junior research staff
Follow policies and procedures established in the SPRI Employee Handbook; adhere to SPRI safety policies.
Maintain a professional commitment to the Steadman Philippon Research Institute mission and values.
KNOWLEDGE, EXPERIENCE AND SKILL REQUIREMENTS:
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.
Good presentation skills: ability to present to diverse groups of clinical staff (internal and external).
Proven organizational skills; ability to manage multiple priorities and work under pressure.
Extensive knowledge of clinical study and drug development process, GCP/ICH guidelines and SOPs.
Attention to detail required.
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.
About Steadman Philippon Research Institute
The Steadman Philippon Research Institute is known throughout the world for our research into the causes, prevention and treatment of orthopaedic disorders. We are committed to solving orthopaedic problems that limit an individual's ability to maintain an active life. Our perspective is based on clinical relevance, with a goal of improving the care of the patient. Recognizing that the body's innate healing powers can be harnessed and manipulated to improve the healing process has led to exciting advances in surgical techniques.
Building on our legacy of excellence in orthopaedic sports medicine, SPRI is unlocking the secrets of healing, finding cures and enhancing lives through global leadership in regenerative medicine, scientific research, innovation and education.