Study Startup Specialist
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Job Location:
Monthly Salary:
Posted on:
2 days ago
Vacancies:
1 Vacancy
Job Summary
Take your career to the next level and lead challenging study activation process on a country level. You will support clinical research teams and ensure PSI projects start smoothly and on time.
You will:
- Perform study startup activities and support all processes critical for site activation
- Collect site documents for IRB/IEC submission and/or IP-RED process
- File study-specific documentation in TMF in accordance with Document management plan
- Assist in feasibility research and site identification upon request
- Support site agreement and budget negotiations upon request
- Coordinate translation and review of study-specific documents
- Identify and escalate project-specific issues as needed
- Prepare and submit IP-REDs packages
- Ensure 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
- Ensure exchange of information and documentation with investigational sites off site facilities and vendors
- Participate in development of site-specific startup timelines and enrolment projections and is responsible for meeting the site activation targets under supervision
Qualifications :
- College/University degree in Life Sciences or an equivalent combination of education training and experience
- At least 2 years of full-scope Study Startup experience in the country/region
- Full working proficiency in English
- Well-developed communication and organizational skills
- Ability to negotiate and build relationships at all levels
Additional Information :
We offer:
- Excellent working conditions
- Extensive training and friendly team
- Competitive salary and benefits package
- Opportunities for personal and professional growth
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 :
No
Employment Type :
Full-time
Key Skills
- Sales Experience
- Crane
- Customer Service
- Communication skills
- Heavy Equipment Operation
- Microsoft Word
- Case Management
- OSHA
- Team Management
- Catheterization
- Microsoft Outlook Calendar
- EHS
About Company
PSI is a leading full-service global Contract Research Organization whose key strength is predictable patient enrollment across multiple therapeutic areas. PSI is known in the industry as a CRO focused on on-time project delivery. This is achieved through investing substantial effo ... View more
