Study Start Up Specialist
Study Start Up Specialist
Posted on :
06-04-2025
Employer Active
1 Vacancy
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Job Description
Support Project Management Regulatory and Contract and Legal in all siterelated startup activities. Establish relationships with study personnel at sites and act as main Alimentiv contact during site startup. Prepare distribute and followup on startup documents with sites. Plan and track site start up activities and data using designated systems and tools. Provide reports on intelligence and metrics related to study startup activities.
Site StartUp Packages
- In cooperation with Project Management create studyspecific startup document package.
- Distribute and follow up with sites to obtain the required executed documents.
- Review content and correctness of returned documents from the sites in accordance with internal standards.
- In conjunction with Regulatory Affairs ensure that the correct and complete packages are obtained within the planned timelines.
Site Contract and Budget Negotiation
- In cooperation with Contract and Legal obtain feedback on suggested site and investigator contract language.
- Act as main point of contact for sites to obtain feedback on budget and contract negotiations.
- In conjunction with the Project Manager provide sites with the suggested study budget and negotiate within preapproved margins.
Site Intelligence Tracking
- Maintain site intelligence tracker with data related to specific requirements for study sites such as startup timelines budget contract negotiation timelines and prerequisites patient recruitment data etc.
- Provide input for suggested site list during startup using past experiences with potential studysites.
Site StartUp Planning and Tracking & Project Management support
- Act as main contact for study sites during startup.
- Develop and maintain relationships with study sites that will facilitate timely completion of startup.
- In conjunction with project management and CRAs plan startup actions and provide expected SIV dates for individual sites based on previous startup metrics as well as regulatory and /RB timelines.
- Track progress of startup activities in smart sheet and/or CTMS.
- Maintain up to date knowledge ensure adherence and compliance with local regulatory requirements and associated documentations.
- Provide support to project management with study related activities as required.
Qualifications
- Applicants should have a minimum of one to three years of related work experience with ongoing training or a minimum of a oneyear College Advance Diploma/Degree in a relevant field of study preferable in Health or Life Sciences or Clinical Research. The successful candidate must exhibit the following skills: Excellent communication skills. Knowledge of startup requirements for clinical sites. Experience in working directly with clinical study sites through previous involvement in studies. Very high sense of urgency.
Working Conditions
- Homebased
a year
Bonus
PHISHING SCAM WARNING: Alimentiv is aware of the continued increase of phishing scams leveraging various methods of attack via email text voice and social media. Please note that Alimentiv only uses company email addresses which contain @alimentiv to communicate with candidates via email. If you are contacted by someone about an open job at Alimentiv please verify the domain of the senders email address and that they are asking you to apply on this website. If you believe youve been a victim of a phishing scam please contact your local government cyber authority to report.
*Accommodations for job applicants with disabilities are available upon request.
Required Experience:
Unclear Seniority
Employment Type
Full-Time
Key Skills
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