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MSD Clinical Trial Coordinator 
Thailand, Bangkok 
175316274

11.08.2024

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:
Trial and site administration:

  • Track (e.g. essential documents) and report (e.g. Safety Reports)

  • Update clinical trial databases (CTMS) and trackers

  • 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

  • Update manuals/documents (e.g., patient diaries, instructions)

  • Document proper destruction of clinical supplies.

  • Prepare Investigator trial file binders

  • Obtain translations of documents


Regulatory & 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 legislation


Budgeting, Agreement and Payments:
Where needed, collaborate with finance/budgeting representatives for:

  • 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

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

  • Excellent negotiation skills for CTCs in finance area

  • 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 (health sciences, healthcare preferred)

Current Contingent Workers apply


Not Applicable


*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.