Seeking a strategic, hands-on, and problem-solving individual with prior industry knowledge to lead clinical programs. This person will support the company's global regulatory strategy and post approval medical evidence requirements. The Director of Clinical Operations will play a key role in the future success of the company and will be a highly visible individual, both inside and outside of the organization in shepherding clinical trials.
location: Monmouth Junction, New Jersey
job type: Permanent
salary: $150,000 - 165,000 per year
work hours: 9 to 5
- Forecasts, develops and administers the clinical development program's budget and timelines
- Responsible for adherence to timetables and budgets as outlined in the clinical development plan
- Responsible for program/trial progress for both country (i.e. US) and global projects as applicable
- Responsible for clinical team's adherence to ICH and GCP guidelines relating to trial practices
- Oversees selection and management of all clinical vendors with focus on efficiency and deliverables
- Serves as escalation point of contact for all clinical management and vendor management issues
- Undergraduate degree in a clinical, biological, scientific, or health-related field from an accredited institution; a licensed health care professional (i.e. registered nurse); or equivalent work experience required.
- Read, write and speak fluent English
- 10-15+ years' experience in clinical trial management, preferably with device experience
- Experience with complex trials
- Budget/finance experience on a project level and full understanding of project financials
- Drug development or experience with device development strongly preferred
skills: CRF, Clinical research, Clinical Data Management, GCP (Good Clinical Practice), Clinical Study Design, CTMS (Clinical Trial Management Systems), ICH Regulations
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.