Clinical Trial Project Manager - CRO MNC

Recruit Express Pte Ltd| Date Posted: 14-May-2020
EA Licence No: 99C4599|EA Personal Registration No: R1875164
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Job Nature:
Permanent, Contract
Position Level:
Experienced, Manager
Qualification:
Bachelor's / Honours, Masters / PhD

Job Description

Responsibilities and Duties

  • 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
  • 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 "Clinical Project Leader" (CPL) and/or relevant functional lead, 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
  • Overall responsible to ensure appropriate project files are set up and maintained accurately and in timely manner, to ensure compliance to ICH E6 GCP, applicable local regulatory and project requirements
  • 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.

Job Requirement:

  • Minimum bachelor degree (major in nursing, pharmacy or other science-related background) and/or equivalent combination of training and experience Certificate in basic and/or advanced GCP course
  • Certificate in monitoring or basic clinical trial management courses
  • 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  
  • Preferably has experience in coordination and/or preparation for site/CRO audit  
  • Preferably has experience in clinical study monitoring and co-monitoring
  • Good understanding of cross-functional processes, clinical trial processes and regulatory environment
  • Ability to manage time/prioritize, multi-task, work independently and follow through with assigned tasks
  • Able to work under pressure and under challenging timelines when required        
  • Possess strong sense of responsibility, dedication with strong work ethic and personal discipline
  • Self-initiative to perform duties 
  • High integrity in personality and professionalism
  • Possess strong project management and coordination skills

Interested candidates please submit your resume to [Click Here to Email Your Resume]

 

Jace Choo Oi Kei
Personnel EA License No.: R1875164
Recruit Express Pte Ltd (EA Licence No.: 99C4599)

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