Local Study Associate Director – FSP
IQVIA
full-time
Posted on:
Location Type: Office
Location: Bucuresti • Romania
Visit company websiteExplore more
Job Level
About the role
- Direct and manage the delivery of all required site activation, maintenance and regulatory activities for selected studies
- Oversee the execution of Site Activation and/or Maintenance for assigned projects
- Develop, implement and maintain the Management Plan according to the Scope of Work and Project Plan
- Ensure collaboration across Regulatory & Site Activation
- Create and/or review technical and administrative documentation
- Provide specialist regulatory and technical scientific support
- Provide overall guidance and oversight of multi-regional and multi-protocol programs
- Identify regulatory complexity and challenges
- Assess and review the regulatory landscape
- Execute operational strategy/ expectations for maintenance of clinical study approvals
- Mentor and coach colleagues as required
Requirements
- Bachelor's Degree Related field
- 6 years clinical research experience, including 3 years' experience in a leadership capacity.
- Full knowledge of drug development process
- Full knowledge of applicable regulatory requirements, SOPs, and company’s Corporate Standards
- Strong knowledge of budget management and resourcing
- Considerable working knowledge of medical terminology
Benefits
- Health insurance
- Retirement plans
- Paid time off
- Professional development
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical researchregulatory requirementsdrug development processbudget managementmedical terminologyproject managementtechnical documentationsite activationmaintenance activitiesregulatory landscape
Soft Skills
leadershipcollaborationmentoringcoachingguidanceoversightcommunicationproblem-solvingstrategic thinkingadaptability
Certifications
Bachelor's Degree