Regional Regulatory Manager
F
Flourish ResearchClinical Research
United StatesFull-TimeManager
Salary not disclosed
Apply NowOpens the employer's application page
Job Details
- Experience
- Minimum of 5+ years’ experience in clinical or biological research.
- Required Skills
- GCPTeam managementProcess improvement
Requirements
- Minimum 5+ years of experience in clinical or biological research.
- Experience must include 3 years in a relevant department plus 2 years in a related role within the clinical research industry.
- Exceptional knowledge of clinical research methods.
- Strong management and leadership skills.
- Demonstrated ability to collaborate and align with operations.
- Excellent interpersonal, written, and oral communication skills.
- Strong critical thinking, risk assessment, and impact analysis abilities.
- Excellent computer skills, including Microsoft Office 365.
- Ability to work independently and influence others effectively.
- High school diploma (college degree preferred).
- Must be able to travel up to 50%.
Responsibilities
- Oversee and coordinate regulatory documents and activities for regional clinical research studies.
- Manage regulatory start-up timelines and staff activities.
- Lead regulatory aspects of audits and inspections.
- Oversee preparation, submission, and maintenance of IRB submissions, amendments, and renewals.
- Mentor, train, and manage team members, including performance reviews and hiring.
- Collaborate with site leadership, principal investigators, sponsors, and CROs.
- Identify and implement process improvements for regulatory efficiency.
View Full Description & ApplyYou'll be redirected to the employer's site
