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Clinical Trial Coordinator

4 months ago

กรงเทพมหานคร, Thailand MSD (THAILAND) LTD. Full time

**Trial and site administration**:

- 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
- 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
- Update manuals/documents (e.g., patient diaries, instructions)
- Document proper destruction of clinical supplies.
- Prepare Investigator trial file binders
- Obtain translations of documentsRegulatory & Site Start-Up responsibilities: Collaborate with other country roles to:

- In a timely manner, 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 legislationMeeting 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.
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**: Bachelor's Degree.
Search Firm Representatives Please Read Carefully

**Employee Status**:
Regular

**Relocation**:VISA Sponsorship**:Travel Requirements**:Flexible Work Arrangements**:
Hybrid

**Shift**:Valid Driving License**:Hazardous Material(s)**:
**Job Posting End Date**: 05/31/2024.
**Requisition ID**: R291477.
**Job skills required**: Excel, English, Research