Clinical Project Manager

The Clinical Project Manager is responsible for managing and coordinating operational activities involved in the planning, conducting, and execution of assigned clinical trials. This includes development and management of timelines, deliverables, budgets, and ongoing risk mitigation. They will lead and participate in cross-functional project teams to ensure the project is completed on time, within budget, and with high quality:

* Assist the scientific staff in developing and reviewing protocols, investigator brochures, informed consent forms, clinical study reports and other scientific documents
* Assist with IND/CTA submission preparation
* Oversee the development of plans and execution of those plans related to site monitoring, safety management, data management and biostatistics
* Identify, evaluate, and recommend external vendors and assist in the development of contracts for and provide oversight of vendors
* Oversee the identification, selection and proper initiation of sites
* Oversee development of CRFs, clinical and safety databases, and shell Tables, Figures and Listings
* Plan, coordinate and conduct investigator meetings; Plan, coordinate and conduct Data Safety Monitoring Board meetings
* With Medical Affairs, assess trends in data including adverse events, protocol violations, etc.
* Oversee timely database freeze and database lock. Participate in data review meeting.
* Maintain the Trial Master File for assigned project and oversee the archival process
* Ensure adherence to SOPs, Good Clinical Practice and FDA/ICH regulations

Education / Skills Requirement:

* Bachelors Degree in scientific discipline or pharmacy, RN, or BSN degree or equivalent
* 5-10 years of clinical trial experience including a minimum 2 years of project management experience
* Oncology background or experience is required
* Ability to travel approximately 20-30% travel based on study demands
* Effective written communication skills and computer skills are required
* Must possess the ability to work closely with all disciplines within a small company, displaying innovative thinking, a strong sense of responsibility and accountability, and integrity
To find out more about Real please visit www.realstaffing.com