Serves as subject matter expert within the organization equipped to help resolve global site contracting issues, and escalation point within the Company for internal customers to seek assistance.
Oversees negotiations of clinical study agreements (CTAs) on a study level and drives CTA document finalization and execution, including contractual language & terms, financial attachments, and investigator grant budgets in collaboration with a global team of site contract & budget negotiators.
Provides oversight of contact & budget negotiations status and manages escalation of out-of-parameter queries on budgetary and contractual requests to sponsor decision-makers in all regions of study conduct. Provides consultation during escalation of out-of-parameter queries as needed.
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Serve as primary contact for investigators and with the local regulatory authorities (in collaboration with the local regulatory manager for complex issues) to ensure submissions are managed in a timely manner.
Ensure guidelines and processes are followed for effective internal team communications as well as communications with investigators, and with the country regulatory authorities to ensure submissions are managed in a timely manner.
Act as a key-contact at country level for all submission-related activities.
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Maintain regular communication with investigative sites between monitoring visits to ensure protocol adherence, timely data entry, and resolution of outstanding issues.
Support investigator payment activities and contribute to the timely resolution of monitoring findings in partnership with cross-functional project team members.
Participate in investigator meetings and support site identification, qualification, initiation, and close-out activities in accordance with study requirements, applicable regulations, and ICH-GCP.
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