Duration 1 year (Start end Feb 2025)
Salary : up to 4500
Location: Boon Lay
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:
• Min. Bachelor’s Degree in health care, life sciences or related field
• Has prior 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
• Solid experience of electronic document management system(s) and eTMF
• 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
If interested, please email your resume to [email protected] or telegram me @alexgohhl
Alex Goh Hock Leong (Alvin)
Recruit Express Pte Ltd (Healthcare & Lifescience)
Company EA Licence number : 99C4599
Personnel EA License: R1763413
