Lead the site identification to site activation on Full Service and/or Medical
R&D Clinical Trials, in collaboration with the Sponsor, Project Management,
Monitoring and Site Management, Regulatory Affairs, and Contracts and Legal.
Develop and utilize intelligence databases and tools to identify the ‘best fit’
sites for a study. Establish relationships with study personnel at sites and act
as the main Alimenitv contact during site start-up. Prepare, distribute and
follow-up on start-up documents with sites. Plan and track site start up
activities using designated systems and tools, present overview to Sponsor and
Study team during review meetings. Identify and initiate best practices,
reports on intelligence and metrics related to study start-up activities.
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Site Start-Up Planning and Tracking & Project Management Support
- Primary contact and lead for study site start-up
- Oversee Startup Specialist/s that may additionally support the study
- Provide guidance, tools, and best practices to support Project Management to
drive faster study startup, including the creation of the overall study
critical path timelines
- Develop and maintain relationships with study team and sites to facilitate
timely completion of start-up activities.
- Proactively plan priorities with the collection of site essential documents
based on regulatory submissions and approvals
- Track progress of startup activities and provide status reports on an ongoing
basis
Site Feasibility
- Contribute to the country and site selection strategy for a study by
utilizing intelligence databases and tools to identify the ‘best fit’ sites
for a study
- Contact and collect feasibility data from sites working closely with
contracts and legal to ensure CDAs are in place, if required, and provide
information to Project Management and Monitoring and Site Management
- Ensure that sites move through the feasibility process promptly, tracking
each step and identifying risks to start-up timelines, potentials barriers
and escalate to the project manager
- Contribute to the identification and initial feasibility of new sites
Site Start-Up Packages
- In cooperation with Project Management and Regulatory Affairs create
study-specific start-up 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.
- Support Regulatory and sites with local EC site submission packages, tracking
of document versions and approvals, when required
Site Contract and Budget Negotiation
- In co-operation 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, create and provide sites with the
suggested study budget and negotiate within pre-approved margins.
- Contribute to the development of the site contracting and site budget
intelligence databases
Site Readiness
- Ensure essential document package for IP release is complete and signed,
working closely with Project Management, Regulatory Affairs and Contracts &
Legal
- Oversee the tracking of pre-site activation activities working with Project
Management, CIMS, Monitoring and Site Management, to ensure expedited site
activation.
Contributions to the development of the Study Startup Team
- Contribute and maintain the study startup intelligence databases
- Identify process improvements, updates to quality and guidance documents
- Contribute to new innovations introduced to improve and expedite the site
startup process
- Providing guidance/mentorship/support to more junior members of the team
Qualifications
- Undergraduate degree (Bachelor’s or Honours Bachelor’s) with minimum 4–6
years of relevant experience
- Bilingual in French/English strongly preferred
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$78,000 - $130,000 a year
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