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Job Description
Under the oversight of the line manager, this role is responsible for comprehensive trial and site administration and involves preparing, collating, distributing and archiving clinical documents. The CTC supports clinical supply & non-clinical supply management and ensures timely maintenance of tracking and reporting tools, as applicable.
Responsibilities include, but are not limited to:
Budgeting, Agreement and Payments:
Develop, control, update and close-out country and site budgets (including Split site budget)
Develop, negotiate, approve and maintain contracts (e.g. CTRAs)
Track and report contract negotiations
Update and maintain contract templates (in cooperation with Legal Department)
Calculate and execute payments (to investigators, vendors, grants)
Ensure adherence to financial and compliance procedures
Monitor and track adherence and disclosures
Maintain tracking tools
Obtain and process FCPA documentation in a timely manner
Trial and site administration:
Track (e.g. essential documents) and reports
Ensure collation and distribution of study tools and documents
Update clinical trial databases (CTMS) and trackers
Document management:
Prepare documents and correspondence
Collate, distribute/ship, and archive clinical documents, e.g. eTMF
Assist with eTMF reconciliation
Support preparation of submission package for IRB/ERC and support regulatory agencies submissions, as applicable.
Meeting Planning:
Organize meetings (create & track study memos/letters/protocols)
Support local investigator meetings (invitations, prepare materials, select venue, support vendor where applicable)
Current Contingent Workers apply
Skills:
Qualification & Experience:
*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.
A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
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