Clinical Trial Coordinator

1 week ago

กรงเทพมหานคร, Thailand MSD (THAILAND) LTD. Full time

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.
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).
Search Firm Representatives Please Read Carefully
**Employee Status**:
Regular
**Relocation**:VISA Sponsorship**:Travel Requirements**:Flexible Work Arrangements**:
Not Applicable
**Shift**:Valid Driving License**:Hazardous Material(s)**:Job Posting End Date**:
**Job Posting End Date**: 09/30/2024.
**Requisition ID**: R308103.
**Job skills required**: Excel, English, Research, Compliance
**Job skills preferred**: Finance, Negotiation

  • Clinical Trial Manager

    5 days ago

    กรุงเทพมหานคร, Thailand Icon plc Full time

    **Overview**: **Role: Clinical Trial Manager** **Location: Thailand, home-based** As a Clinical Trial Manager, you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. - You will be partnering with one of the world’s premier Biopharmaceutical companies. Working across a vast...

  • Clinical Trial Coordinator

    2 days ago

    กรุงเทพมหานคร, Thailand MSD (THAILAND) LTD. Full time

    **Trial and site administration**: - Clinical supply & non-clinical supply management (mainly focus on import and export), in collaboration with other country roles. - Update clinical trial databases, report and trackers as required - Ensure collation and distribution of study tools aFnd documents. **Document management**: - Prepare documents and...

  • Clinical Trials Assistant 1

    7 days ago

    กรุงเทพมหานคร, Thailand IQVIA Full time

    **Job Overview** Perform daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a complete and accurate Trial Master File delivery. Essential Functions - Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining...

  • Clinical Trial Educator

    2 weeks ago

    กรุงเทพมหานคร, Thailand IQVIA Full time

    The Clinical Trial Educator (CTE) group is looking to appoint a **Clinical Trial Educator **in** IQVIA Thailand**. As our specialist CTE, you will be able to accelerate patient enrollment, improve site performance and help streamline studies in ways no other team member can. You’ll often be your sites’ go-to person for information, advice and problem...

  • Clinical Team Leader

    5 days ago

    กรุงเทพมหานคร, Thailand Novo Nordisk Full time

    **About the Department** Novo Nordisk is a global healthcare company with more than 95 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help people defeat obesity, haemophilia, growth disorders and other serious chronic diseases. Headquartered in Denmark, Novo Nordisk employs...

  • Clinical Trial Educator

    2 weeks ago

    กรุงเทพมหานคร, Thailand Novasyte Full time

    IQVIA Thailand is currently looking to hire a motivated, creative, and enthusiastic clinical trials professional to join our team as a Clinical Trials Educator (CTE) on a 12-months fixed term contract. As our specialist CTE, you will be able to accelerate patient enrolment, improve site performance and help streamline studies in ways no other team member...

  • Clinical Research Associate

    2 days ago

    กรุงเทพมหานคร, Thailand MSD (THAILAND) LTD. Full time

    Develops strong site relationships and ensures continuity of site relationships through all phases of the trial. Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents. Gains an in-depth understanding of the study protocol and...

  • Clinical Research Associate

    5 days ago

    กรุงเทพมหานคร, Thailand MSD (THAILAND) LTD. Full time

    Develops strong site relationships and ensures continuity of site relationships through all phases of the trial. Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents. Gains an in-depth understanding of the study protocol and...

  • Clinical Research Associate

    2 weeks ago

    กรุงเทพมหานคร, Thailand MSD Full time

    **THE OPPORTUNITY** The role is accountable for performance and compliance for assigned protocols and sites in a country. Under the oversight of the CRA manager the person ensures compliance of study conduct with ICH/GCP and country regulations, Merck policies and procedures, quality standards and adverse event reporting requirements internally and...

  • Clinical Operations Manager

    7 days ago

    กรุงเทพมหานคร, Thailand MSD Full time

    **Job Description**: This role is accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, company policies and procedures, quality standards and adverse event reporting requirements internally and externally. Under the oversight of the SCOM or CRD, the person is responsible for...