MSD Clinical Trial Coordinator 

Thailand, Bangkok 

175316274

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.