Clinical Principal Consultant
- Posted: over a month ago
DataRevive USA LLC is a regulatory consulting company helping pharmaceutical and biotech companies with their regulatory filing of US IND, BLA, and NDA during drug development. We specialize in both small molecule and biologic product regulatory affairs with specific expertise in CMC (chemistry, manufacturing, controls), nonclinical, clinical pharmacology and clinical areas. For more information, go to www.data-revive.com.
The Clinical Principal Consultant will be focused on the functional areas of clinical design and clinical development.
Essential Duties & Responsibilities:
- Performing a leadership role on the clinical team
- Manager for group of clinical team members to include training, mentoring, workload, and administrative management
- Attending and/or leading the FDA clinical meeting for clients
- Other duties and responsibilities as required
- 5-10 + years with relevant industry or FDA experience
- Excellent written and oral communication skills
- Experience managing, leading and developing employees
- Project management experience to coordinate delivery of multiple projects by deadline
- Manage client and key stakeholder relationships
- Prolonged periods of sitting at a desk and working on a computer.
What we offer you:
You’ll be a member of a phenomenal group of business professionals that have an innovative and team approach to success, based out of Rockville, MD. DataRevive offers tremendous learning opportunities and employees are actively encouraged to creatively contribute. Our benefits are comprehensive and include medical, dental, vision, 401(k) matching, and generous flexible vacation and sick time allowances.
DataRevive USA LLC provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, Validant complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.
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