Senior Study Startup Specialist
Senior Study Startup Specialist
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
- Coordinates study startup activities with the local project team and supports all processes critical for site activation.
- In the absence of stand-alone feasibility function leads activities in feasibility research and site identification process.
- Facilitates site agreement and/or budget negotiations with sites to ensure alignment to the site activation plan.
- Leads site document collection for IRB/IEC submission and/or IP-RED process.
- Reviews study-specific translations.
- Identifies project-specific issues and escalates to Regional (Startup) Lead/PM and operational Manager in the country.
- Under supervision prepares and submits the study dossiers to investigators/institutions competent authorities IRBs/IECs.
- Ensures quality of IP-REDs packages.
- Ensures initial distribution of locally obtained clinical study supplies to sites and supervises initial distribution of Investigational Product(s) and centrally obtained clinical study supplies to sites.
- Develops site-specific startup timelines and enrolment projections and is responsible for meeting the site activation targets under supervision.
- Provides startup-related training and methodological support to operational staff within the country/region.
- Provides on-the-job coaching of department staff.
- Supports preparation for audits on a country /regional level.
- Upon completion of the project startup phase supports the preparation of a summary on operational challenges best practices and lessons learned and reports to Study Startup management and other functions concerned.
Qualifications :
- University/college degree or an equivalent combination of education training and experience
- At least 4 years experience in clinical research.
- At least 3 years of full-scope Study Startup experience
Additional Information :
Make the right call and take your career to a whole new level. Join the company that focuses on its people and invests in their professional development and success.
Remote Work :
Yes
Employment Type :
Full-time
Employment Type
Remote
Company Industry
Key Skills
- Computer Hardware
- Mac Os
- Manufacturing & Controls
- Root cause Analysis
- Windows
- Customer Support
- Remote Access Software
- Operating Systems
- Encryption
- Remedy
- Chemistry
- Cerner
