Director, Cardiac Safety Services
|Title:||Director, Cardiac Safety Services|
|Department:||Early Clinical Research|
DescriptionCelerion is the premier provider of innovative early stage clinical research solutions. From facilities strategically located around the world, advanced scientific and technological expertise is applied to global clinical research (over 730 beds in Phases 0, I and IIa, NDA-enabling clinical pharmacology, ADME), clinical pharmacology sciences, global bioanalytical services (discovery through late stage), and drug development services. Celerion has a full spectrum of resources to meet the needs of the pharmaceutical, biotechnology and generic industries for Phase 0 through IIa proof-of-concept studies.
Celerion has an outstanding opportunity for a Director, Cardiac Safety Services who will have overall responsibility for management and efficiency of Thorough QT (TQT) studies globally.
Primary responsibilities include:
- Establishment of consistent processes for recording and processing ECG and Holter monitor data at all clinical facilities globally
- Relationship management with sponsors, central ECG vendors, and operations to facilitate start-up and conduct of TQT clinical studies
- Progress oversight and monitoring of all TQT studies at all our global clinics to ensure generation of high quality and consistent data, includes management of multi-site studies
- Ability to stay abreast and communicate pertinent regulatory guidelines regarding TQT studies
- Collaboration with the Medical Writing group to develop TQT protocols
- Collaboration with Business Development team to facilitate the sales process and award of these studies
- Attendance at scientific conferences, symposia, webinars and external seminars to promote Celerion’s capabilities and provide awareness for TQT studies
- Responsibility for staff management in accordance with the organizational policies and applicable laws. Includes interviewing, hiring, and training employees; planning, assigning and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems; development and coaching of employees.
We require a bachelor’s degree in the life sciences with preference for a BSN or PharmD and a minimum of 5-7 years of experience working on clinical studies, as well as extensive experience with ECG and Holter devices. The desired candidate must have excellent oral and written communication skills, strong customer service and interpersonal skills and the ability to manage multiple priorities while staying organized. Approximately 20% travel will be required.
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We are an equal opportunity employer
Celerion is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, genetic information, marital status, qualified protected veteran status, or disability.