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 (Clinical Trial Coordinator) 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: Trial and site administration: Ensure collation and distribution of study tools and documents Clinical supply & non-clinical supply management, in collaboration with other country roles Manage Labeling requirements and coordinate/sign translation change request, in collaboration with other country roles (if applicable) Document management: Prepare documents and correspondence Collate, distribute/ship, and archive clinical documents, e.g. eTMF Assist with eTMF reconciliation Execute eTMF Quality Control Plan Document proper destruction of clinical supplies. Prepare Investigator trial file binders Meeting Planning: Organize meetings (create & track study memos/letters/protocols) Support local investigator meetings (invitations, prepare materials, select venue, support vendor where applicable) Skills: • Fluent in Local Languages and business proficient in English (verbal and written) and excellent communication skills • Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines. • Hands on knowledge of Good Documentation Practices • Good IT skills (Use of MS office, use of some clinical IT applications on computer) and ability to adapt to new IT applications. Strong MS Excel skills required. • ICH-GCP Knowledge appropriate to role • Effective time management, organizational and interpersonal skills, conflict management • Effective communication with external customers (e.g. sites and investigators) • High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment • Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships. • Demonstrates commitment to Customer focus, both internally and externally. • Able to work independently • Proactive attitude to solving problems / proposing solutions • Positive mindset, growth mindset Qualification & Experience: Completed job training (office management, administration, finance, health care preferred) or Bachelor’s Degree Employee Status: Project Temps (Fixed Term) Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Hybrid Shift: Valid Driving License: Hazardous Material(s): Job Posting End Date: 04/21/2025 *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. Requisition ID: R341445 #J-18808-Ljbffr