Homeoffice Sr. Study Start-Up Specialist na Alimentiv-2

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.



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

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