Regulatory and Site Activation Sr Analyst
Share
Job Location:
Monthly Salary:
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
Job Overview
Under general supervision perform tasks at a country/region level associated with site activation activities in accordance with applicable local and/or international regulations standard operating procedures (SOPs) project requirements and contractual/budgetary guidelines. May also include feasibility or maintenance activities.
Essential Functions
Under general supervision perform feasibility site activation and some maintenance activities in assigned studies for investigative sites according to applicable regulations SOPs and work instructions working closely with the Site Activation Manager (SAM) Project Management team and other departments as necessary. Review documents for completeness consistency and accuracy under guidance of senior staff.
Prepare site documents reviewing for completeness and accuracy.
Inform team members of completion of regulatory contractual. and other documents for individual sites.
Distribute completed documents to sites and internal project team members.
Support the updating and maintenance of internal systems databases tracking tools timelines and project plans with accurate and complete project specific information.
Review track and follow up the progress the approval and execution of required documents such as questionaires CDAs regulatory ethics Informed Consent Form (ICF) and Investigator Pack (IP) release documents.
Qualifications
Bachelors Degree Life science or related field.
With 2 years experience in a healthcare environment working in regulatory activities (contracting submissions import regulatory process regulatory entity legislation).
Good attitude desire to continue learning good behavior good communication.
English Level: Intermediate - advanced conversational.
IQVIA is a leading global provider of clinical research services commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at
Required Experience:
Senior IC
Key Skills
- Business
- Marketing
- Key Decision Makers
- Active Directory
- Customer Service
- Performance Evaluations
- Federal Regulations
- Communications
- Account Management
- Project Management
- Minimum Data Set
- Budget management
- Powerpoint
- Direct Reports
About Company
IQVIA is the Human Data Science Company™. We are inspired by the industry we serve and provide solutions that enable life sciences companies to innovate with confidence, maximize opportunities and ultimately drive human health outcomes forward. Our approach is Human Data Science – a d ... View more
