Support Clinical Project Managers (CPMs) and study team with administrative, documentation, TMF, budget management and logistic activities related to Clinical studies during the operational phase of clinical trials to ensure the timely delivery of quality data while complying with internal Standard Operating Procedures, applicable laws and ICH Good Clinical Practice.
Jobscope:
• Supports high-quality electronic Trial Master Files (eTMFs). Performs set-up, maintenance (filing and approving documents) and archiving of eTMFs.
• Provides CRO oversight by developing eTMF guidelines, establishing review processes, and ensure the filing completeness.
• Manages documentation of clinical studies in compliance with Good Clinical Practices (GCP) and relevant Standard Operating Procedures (SOPs) and perform filing QC "
• Supports CPMs with vendor creation, budget and invoice management: checking of good receipt and payments, uploading invoice information in Finance budget tool, assist on planning of commitments monthly and keeping track of actual spending for each study
• Supports maintenance of clinical studies management tracking tools and trackers. Support study team to register study on ct.gov.
• Assists study team with trial management logistical support (sample or ancillary shipments, procurement of study supplies, organizing trainings).
• Assists study team in the quality check of protocols, informed consent forms and advertisement materials to ensure compliance with SOPs and regulatory requirements.
• Supports organization of clinical meetings (internal meetings, meetings with CROs, Investigators meetings, etc.) including agenda, minutes, logistics.
• Assists in managing global communications (e.g., Newsletters, emails, website posting). "
• Assists with the preparation, review and maintenance of SOPs, work instructions, training materials, and templates related to project activities.
Requirement:
• Bachelor’s Degree in health care, life sciences or related field with demonstrable related experience in in Food/Pharma/CRO industry or in an academic setting
• Records management experience in a GCP-regulated environment.
• Experience in clinical trials in Nutrition is an advantage
• Good knowledge of Good Clinical Practices (GCP), regulations/guidelines and of the quality control process and compliance requirements in relation to TMF
• Proficient and agility in common office technology e.g. Microsoft tools, teleconferencing, etc.
• Strong general administrative skills and a minimum of 2 years of clinical studies administration experience
• Educational background in biological science or other relevant science.
TELE me at @yijingggggg or WA me at https://wa.me/+6598623556 NOW!
Interested candidates, please submit your resume to [email protected]
Alison Chen
Outsourcing Team
Recruit Express Pte Ltd (EA Licence No.: 99C4599)
