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
- Leads individual clinical development programs
- Oversee patient recruitment and retention
- Is responsible for ensuring that the clinical team adhere to the appropriate training needs and performance indicators to ensure the validity, correctness, and completeness of the clinical data reviewed and collected at assigned sites as dictated by ICH GCP, protocol
- Takes the initiative to move the project/program forward and leads in country and global projects where applicable
- Is customer focused on both internal and external stakeholders
- Oversees the management of clinical vendors with focus on deliverables
- Supports Clinical Affairs in the development and review of the protocol/study design, case report forms, informed consent forms and other documents
- Forecasts and administers clinical development program budget and timelines
- Interfaces with KOLs and other external stakeholders (Advisory Boards) to provide input to study feasibility, study design including executability, and recruitment timelines.
- Oversees the identification, selection and qualification of all clinical vendors.
- 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 demonstrates a full understanding of project financials
- Understanding of either drug development or experience with device development strongly preferred
- Demonstrated track record of successfully supporting, developing and executing clinical development plans
- An ability to collaborate and communicate effectively internally and externally and to collaborate effectively with internal and external partners including the ability to work in matrixed environments including both company staff and consultants.
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.