Ground breaking science. Advancing medicine. Healing made personal.
The Director of Research Administration is responsible for defining the clinical trial strategy and management of all clinical studies being conducted by ISCI. The Director will manage operational and logistical tasks of clinical development to ensure efficient execution of trials within established budgets and timelines, ensuring all activities occur in compliance with the appropriate regulations, including FDA regulations, IND, IDE, 510 (k) guidelines etc. S/he will coordinate the efforts of internal and external resources to ensure fast patient recruitment, trial site selection, trial plan optimization and execution of trials with a focus on quality.
Duties and Responsibilities:
- Set strategic direction and leads large clinical trials
- Manage clinical research and operations including design and initiation of clinical trials to optimize tactical and clinical value through global site selection and data portability
- Coordinate and oversee clinical trials to support regulatory submissions (IND) as well as post-market clinical trials and clinical preference evaluations
- Assist in training the clinical sites to the protocol
- Work with trial sites to ensure expedient patient recruitment in conjunction with CRO
- Participate in defining clinical application of products and contribute in the development of post-market clinical studies, initiated by domestic and international clinicians
- Author and/or work with others to develop publications based on the results of the clinical trials
- Provide updates and status reports to senior management on a regular basis; report on performance against plan
- Manage the budget for clinical trials. Ensure overall operation is within the approved budget and timeline
- Develop and implement SOPs for clinical trials and related activities
- Ensure compliance with all applicable regulatory standards related to global clinical trials and interactions with physicians
- Develop and maintain professional relationships with academic and community-based physicians, clinicians and investigators to assure good clinical input to ISCI’s product development process, and marketing
- Interface with departments within and outside including Reimbursement, R&D, Regulatory Affairs
- Manage staff and outside partners/service providers
- Represent the department at major annual conferences
- Bachelor’s degree required; Natural or Health Science preferred. Masters degree in related field preferred
- 10+ years of experience in, medical device or pharmaceutical industry with at least five years of hands-on managerial experience running clinical trials and managing teams
- Experience with all aspects of management of large clinical trials from inception to completion
- Strong project planning, leadership, negotiation and presentation skills as well as an ability to contribute creative yet practical solutions to problems
- Extraordinary researching skills and expertise in searching medical literature and databases for clinical and technical information
- Ability to multi-task and manage several projects in parallel, paying attention to detail
- Ability to forge cross-functional working relationships with internal teams and external project partners
- Ability to be proactive in identifying issues and hurdles that may handicap the effective implementation of the trial and resolve the issues in a timely fashion
- Superior writing skills and ability to effectively communicate with technical and non-technical people
- Ability to work in a team environment
- Strong knowledge of FDA regulations and experience with IDE Trials
- Previous clinical trial site management
The Mount Sinai Health System believes that diversity is a driver for excellence. We share a common devotion to delivering exceptional patient care. Yet we’re as diverse as the city we call home- culturally, ethically, in outlook and lifestyle. When you join us, you become a part of Mount Sinai’s unrivaled record of achievement, education and advancement as we revolutionize medicine together.
We work hard to acquire and retain the best people, and to create a welcoming, nurturing work environment where you can develop professionally. We share the belief that all employees, regardless of job title or expertise, can make an impact on quality patient care.
Explore more about this opportunity and how you can help us write a new chapter in our story!
Over 38,000 employees strong, the mission of the Mount Sinai Health System is to provide compassionate patient care with seamless coordination and to advance medicine through unrivaled education, research, and outreach in the many diverse communities we serve.
Formed in September 2013, The Mount Sinai Health System combines the excellence of the Icahn School of Medicine at Mount Sinai with seven premier hospital campuses, including Mount Sinai Beth Israel, Mount Sinai Beth Israel Brooklyn, The Mount Sinai Hospital, Mount Sinai Queens, Mount Sinai West (formerly Mount Sinai Roosevelt), Mount Sinai St. Luke’s, and New York Eye and Ear Infirmary of Mount Sinai.
The Mount Sinai Health System is an equal opportunity employer. We promote recognition and respect for individual and cultural differences, and we work to make our employees feel valued and appreciated, whatever their race, gender, background, or sexual orientation.