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.
The role is critical to meet planned Site Ready dates, including assisting with the preparation of submission packages to IRB/ERC and Health Authorities. The role will collaborate at local level closely with COM, CRM and CRA. And the person collaborates with finance/budgeting representatives to manage CTRAs and payments.
Responsibilities include, but are not limited to:
Principal:
• Budgeting, Agreement and Payments:
Collaborate with finance/budgeting representatives for:
o Develop, control, update and close-out country and site budgets (including Split site
budget)
o Develop, negotiate, approve and maintain contracts (e.g. CTRAs)
o Track and report contract negotiations
o Update and maintain contract templates (in cooperation with Legal Department)
o Calculate and execute payments (to investigators, vendors, grants)
o Ensure adherence to financial and compliance procedures
o Monitor and track adherence and disclosures
o Maintain tracking tools
o Obtain and process FCPA documentation in a timely manner
Desirable:
• Trial and site administration:
o Track (e.g. essential documents) and report (e.g. Safety Reports)
o Ensure collation and distribution of study tools and documents
o Update clinical trial databases (CTMS) and trackers
o Clinical supply & non-clinical supply management, in collaboration with other country
roles
o Manage Labeling requirements and coordinate/sign translation change request, in
collaboration with other country roles (if applicable)
• Document management:
o Prepare documents and correspondence
o Collate, distribute/ship, and archive clinical documents, e.g. eTMF
o Assist with eTMF reconcili
📌 Clinical Trial Coordinator (Lima)
🏢 Msd
📍 Lima