Clinical Trial Project Manager

Recruit Express Pte Ltd| Date Posted: 19-Mar-2021
EA Licence No: 99C4599|EA Personal Registration No: R1440070
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Job Nature:
Permanent
Position Level:
Manager
Qualification:
Bachelor's / Honours

Job Description

  • Undertake the role of Project Manager for designated project(s) and be responsible for overall project management from every aspect to ensure all deliverables are met and client is satisfied with the service delivery and results.
  • Support in operations and/or business's continuality by undertaking tasks such as:
    • Mentoring and training of new employees as require
    • Support business development activities
    • Review, revise
  • Responsible to plan, initiate, develop and organize clinical trials in accordance to the highest standards required in ICH E6 GCP, regulatory compliance, investigator integrity and compliance with the study requirements:
  • Responsible to lead and motivate project team(s) on all project-related issues to ensure all activities are conducted in highest quality standards, in compliance with ICH E6 GCP and applicable local regulatory requirements as well as to meet/exceed sponsor's expectation, under the supervision of project manager(s):
  • Responsible to supervise daily operations and management of activities associated with assigned project(s) from concept to completion of final study report and ensure project goals are achieved:
  • to ensure execution of appropriate communication channels and its documentation.
  • Responsible to lead project team(s), sponsor and vendors, pertaining to logistics management, clinical supplies and investigational product logistics, systems set up and/or any other requirements, are in place to ensure swift study start up:
  • Manage/support project(s) in the capacity of "Project Manager" (PM) and/or “Project Leader” (PL) to undertake all or partial responsibilities and tasks as designated by the Company
  • Develop and oversee applicable clinical systems are accurately set up and maintained in a timely manner, to track the compliance, finance status and performance of the project and site(s) within project timeline, so as to report appropriately to sponsor and internal management:
  • Support and/or conduct monitoring and co-monitoring activities, as required 
  • Support/assist in feasibility studies, site and investigator identification as required 
  • Responsible to ensure that overall, appropriate project files are set up and maintained accurately and in a timely manner, to ensure compliance to ICH E6 GCP, applicable local regulatory and project
  • Coordinate and support/assist in Site and CRO audit or inspection as required:
  • Support Company's operations by assisting/coordinating and conducting orientation and applicable training for new employees as required
  • Support business development activities (e.g. project bidding, RFI, RFP) as required:
  • Review, revise and/or develop Project Management related SOPs, work guides etc:

 

Requirements 

  • Minimum bachelor degree (major in nursing, pharmacy or other bio-science-related background) from a recognized institution, and/or equivalent combination of training and experience
  • Minimum 5 years’ experience in clinical research in healthcare, pharmaceutical and/or CRO industry, or minimum 3 years direct experience in clinical project planning, coordination and management, with multi-national trial exposure  
  • Good understanding of cross-functional processes, clinical trial processes and the regulatory environment
  • Has experience in clinical study monitoring and co-monitoring 
  • Experience in coordination and preparation for site/CRO/Regulatory authority audit 

 

For interested candidates, please send your most recent and updated resume to [Click Here to Email Your Resume]
Subject heading: Clinical Trial Project Mgr


Michelle Lee Ser Min
Recruit Express Pte Ltd
(R1440070)
EA Licence No. 99C4599

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Recruit Express Pte Ltd