Sr. Clinical Trial Coordinator

Under the oversight of the line-manager, this Sr. Clinical Trial Coordinator role is responsible for comprehensive trial and site administration, including 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.

Requirements

• Track (e.g. essential documents) and report (e.g. Safety Reports)
• Ensure collation and distribution of study tools and documents
• Update clinical trial databases (CTMS) and trackers
• Manage Labeling requirements and coordinate/sign translation change request, in collaboration with other country roles (if applicable)
• Prepare documents and correspondence
• Collate, distribute/ship, and archive clinical documents, e.g. eTMF
• Assist with eTMF reconciliation
• Execute eTMF Quality Control Plan
• Update manuals/documents (e.g., patient diaries, instructions)
• Document proper destruction of clinical supplies
• Prepare Investigator trial file binders
• Obtain translations of documents
• Provide to and collect from investigators forms/lists for site evaluation/validation, site start-up and submissions
• Obtain, track and update study insurance certificates
• Support preparation of submission package for IRB/ERC and support regulatory agencies submissions
• Publish study results for GCTO and RA where required per local legislation
• 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
• Organize meetings (create & track study memos/letters/protocols)
• Support local investigator meetings (invitations, prepare materials, select venue, support vendor where applicable)
• Act as process Subject Matter Expert (SME), making recommendations for continuous improvement, providing training as appropriate/required and mentoring junior CTCs

Benefits

• Flexible Work Arrangements: Not Applicable