Director - Clinical Monitoring Sarah Cannon Development Innovations
is a full-service contract research organization (CRO
) that is uniquely focused in oncology. Sarah Cannon Innovations offers strong scientific leadership, access to patients through Sarah Cannon Research Institute's Site Management Organization (SMO) and relationships with other clinical sites, and experience in drug development and delivery of clinical trials from First-In-Man through registration level studies, making us the partner of choice for oncology.
Our differentiator is strong operational delivery in partnership with our Site Management Organization and physician leaders to deliver your program efficiently.
Sarah Cannon Development Innovations works with Sarah Cannon Research Institute strategic and network sites throughout the United States, along with investigators at sites outside of the Sarah Cannon Research Institute network. This reach allows Sarah Cannon Development Innovations to offer sponsors access to a diverse and varied patient population, spanning multiple tumor types and disease stages. These relationships further enhance the depth and breadth of Sarah Cannon Development Innovations' therapeutic expertise, enabling it to provide focused, strategic operational support. This support ensures that clinical trials are conducted in a timely manner and reported with high-quality, registration-standard data.
the global cancer enterprise of Hospital Corporation of America (HCA), offers integrated cancer services with convenient access to cutting-edge therapies for those facing cancer in communities across the United States and United Kingdom. Summary of Position:
As a senior management team member, the Director, Clinical Monitoring assumes line management responsibilities as well as departmental responsibilities aimed at improving the overall quality and delivery of research conducted by Sarah Cannon Development Innovations. The Director is responsible for the operational oversight of the Clinical Affairs monitoring team to include, but not limited to the direct oversight and development of the Clinical Affairs Management team, identifying necessary process improvements and the development and reporting of operational metrics. Duties and Responsibilities
Duties include but are not limited to:
- Ensuring compliance with applicable regulations and Sarah Cannon SOPs.
- Manages the performance of direct reports, including role expectations and performance reviews
- Ensure adequate support, and identify/develop training opportunities for department and individuals.
- Oversee department managers and provide guidance on any staff related or HR issues to the team of managers.
- Develop and write appropriate SOPs and working practice guidelines.
- Responsible for working with the team to develop tools for tracking study specific and departmental metrics that may be shared with Clients as well as Senior Management within Sarah Cannon
- Manage departmental resources to ensure all project teams are adequately supported. This includes forecasting, managing utilization, hiring and training.
- Develop and define career development pathways to ensure stabilization and minimization of staff turnover
- Maintain strong relationships with directors, managers of other functional groups within Sarah Cannon Development Innovations and other Sarah Cannon departments
- Collaborate with Development Innovations Leadership Team to continue to drive business excellence.
- Together with Development Innovations Leadership team, develop and implement standards for department
- Participate in educational activities and programs.
- Maintain strictest confidentiality.
- Serve as a back-up for the Senior Director, Clinical Affairs as needed for both internal and client facing meetings.
- CRA training program oversight
- Travel required - up to 75%
A body of information needed to perform a tasks; May be obtained through education, training or experience
- Strong clinical research knowledge
- Knowledge in Operational Execution
The proficiency to perform a certain task
- Exceptional communication skills (both written and interpersonal)
- Strong management skills
- Strong strategy, team building and information technology skills
An underlying, enduring trait useful for performing duties
Qualifications: Minimum Qualifications Education: Minimum Required:
- Develop and implement functional strategies
- Development and implement departmental strategies
- Abilities to motivate leaders and staff
- Ability to deliver under pressure
- Ability to be proactive in issue identification and problem solving
Bachelors College Degree (4 year program) Preferred:
Master's Degree (1-2 year program) Experience: Minimum Required:
- Extensive Management experience
- Extensive experience in clinical research, specifically in clinical operations/clinical affairs
- Extensive experience as a CRA and CRA Line Manager
**If interested in advancing your career with a growing leader in cancer research please apply today!
- At least 10 years of clinical research experience
- Strong pharma/CRO/biotech management experience
- Early phase Oncology experience
A little about us:
HCA is the nation’s leading private provider of healthcare services. Comprised of locally managed facilities which include 230,000 employees at over 160 hospitals, over 120 surgery centers and 100 urgent care facilities in 20 states and the United Kingdom