Project Operations Specialist (POS) I - CTMS I or II (Vietnam) - CMIC Group | New Day Jobs (Yangon, Myanmar)

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CMIC Group
Remote (Asia Time Zone Permitted)

Project Operations Specialist (POS) I - CTMS I or II (Vietnam)

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Project Operations Specialist (POS) I - CTMS I or II (Vietnam)

CMIC Group
Salary : Login to view salary Apply from Source
Job Type : Contract
Education Requirement : Bachelor Degree
Skills :
Experience : 3 to 5 years
Work Days : Monday To Friday
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Job Detail

The following positions will be 1 year contract position based in our HCM Office or homebased in Ha Noi. The type of contract could be converted to Permanent position after POS performance review.

POSITION PURPOSE:

The overall purpose of this position is to provide leadership: 

  • CTMS management 
  • Departmental support pertinent to the compliance to necessary internal processes, company Corporate and Local Standard Operating Procedures (SOPs) 
  • AND 
  • Support in Projects, eTMF application and associated business processes as formulated by the PM department

RESPONSIBILITIES:

CTMS Management:

1. Act as the primary point of contact for the CTMS user community to provide detailed system support, training and process guidance

2. Function independently as the CTMS System Administrator, directing the day-to-day business ※ usage of the system, and communicating with all impacted functional areas regarding the system 

3. Coordinate CTMS meetings and manage administrative actions  

4. Manage system configuration and maintenance, by collaboration with relevant IT department and vendor. System configuration and specification development, maintenance, and documentation include: 

  • CTMS process development and documentation 
  • New system functionality implementation and system upgrades 
  • Troubleshoot with relevant stakeholders such as GICT, vendor, and project management teams to identify/resolve issues
  • Monitor system performance, identify issues and implement solutions

5. Manage study implementation, including: 

  • Study site configuration and template management 
  • Study site setup and deployment; ongoing maintenance 

6. Ensure user training and support by: 

  • Develop CTMS user guides and training materials 
  • Provide new user onboarding support 
  • Ensure continuing information sharing with the user community 
  • Triage or answer system and business process related questions 
  • Interact with study teams or functional teams as needed 

7. Generate scheduled and unscheduled reports or custom data extractions as needed 

8. CTMS vendor communication

Project Support

9. Responsible for ensuring timely scanning/indexing/retrieval of all documents by the project team

10. Responsible for ensuring that documents are handled and maintained to the required standards by maintaining awareness of current regulatory, legal, and other relevant guidelines

11. Deliver on the strategy for the electronic trial master file system (eTMF), ensuring the operational aspects are handled daily 

12. Oversee indexing and storage system for both electronic and existing paper documents that will allow for identification and retrieval of documents in support of the clinical trial master file 

Department Support

  • Manage functional area documentation and its relates to inspection readiness 
  • Track and manage key actions and agreements when working with vendors, CRO partners and/or other key stakeholders 
  • Establish, maintain, and analyze key performance and operational metrics 
  • Support data entry and management of key operational information as needed in various systems 
  • Provide general support for various forums and meetings including but not limited to meeting planning and organization, generating agenda and minutes, following up on action items 
  • Any other duties as requested by management 

REQUIREMENTS:

Qualifications

  • Minimum diploma or bachelor degree (major in nursing, pharmacy, science or computer science- related background) from a recognized institution, and/or equivalent combination of training and experience

Experience and Skills

  • Minimum 1 year experience in related field or clinical research in healthcare, pharmaceutical and/or CRO industry and has direct experience in assisting clinical project planning, coordinating and management 
  • Strong computer/technology skills including MS Word, MS Excel, PowerPoint etc.
  • Good written and verbal communication skills, preferably with good command of English in addition to local language
  • Good interpersonal and organization skills
  • Basic understanding of cross-functional processes, clinical trial processes and regulatory environment
  • Self-initiative to perform duties
  • Meticulous and able to work in a fast-paced environment
  • Able to work under pressure and under challenging timelines when required
  • Ability to multi-task and follow through with assigned tasks
  • Positive and demonstrate enthusiasm in learning and taking up new challenges

APPLICATION:

Interested parties please apply via email.

Responsible Person Contact details

Name: My Ha

Email: [email protected]

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