MSD (THAILAND) LTD.
Clinical Trial Coordinator (Shipment clearance)
atMSD (THAILAND) LTD.
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:
- Trial and site administration:
o Clinical supply & non-clinical supply management (mainly focus on import and export), in collaboration with other country roles
o Update clinical trial databases, report and trackers as required
o Ensure collation and distribution of study tools aFnd documents
- Document management:
o Collate, distribute/ship, and archive clinical documents
o Assist with eTMF reconciliation and execute eTMF Quality Control Plan
o Document proper destruction of clinical supplies.
o Prepare Investigator trial file binders
- Agreement and Payments: Collaborate with finance/budgeting representatives for:
o Monitor and track adherence and disclosures
o Maintain tracking tools
o Obtain and process FCPA documentation in a timely manner
- 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
- Experience in logistics will be advantage, but not a must
Current Employees apply HERE
Current Contingent Workers apply HERE
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
Regular
Relocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Hybrid
Shift:
Valid Driving License:
Hazardous Material(s):
Requisition ID:R286274
Skills required
- Finance
- Budgeting
- Research
- English (Excellent)
Experience required
- any or no experience
Skills optional
- Excel
- Negotiation
Salary
- Negotiable
Job type
- Full-time
Company overview
Merck & Co., Inc. (Merck) is a global research-driven pharmaceutical company that discovers, develops, manufactures and markets a range of products to improve human and animal health. The Company?s operations are principally managed on a products basis and comprises of two business segments: the Pha ... Read more
