Alimentiv · 5 months ago
Sr. Study Start-Up Specialist
United States
Full-time
Remote
Mid, Senior Level
$86K/yr - $143K/yr
4+ years expAlimentiv is a company focused on clinical trials, and they are seeking a Sr. Study Start-Up Specialist to lead site identification and activation for clinical studies. The role involves collaborating with various teams, establishing relationships with study personnel, and ensuring timely completion of start-up activities.
BiotechnologyClinical TrialsConsultingHealth CarePharmaceuticalPrecision Medicine
Responsibilities
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 Alimentiv 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
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
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
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
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
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
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
Qualification
Required
Undergraduate degree (Bachelor's or Honours Bachelor's)
4–6 years of relevant experience
Benefits
+ bonus
Company
Alimentiv
Industry-leading specialty GI contract research organization (CRO) transforming clinical trial outcomes and accelerating the development of life-changing therapies.
501-1000 employees
Funding
Current Stage
Late StageLeadership Team
Pierre Gaudreault
Chief Executive Officer, Alimentiv
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