Salary: up to $4650
Duration: 1 year contract
Working Days & Hours: Mon-Fri Office Hours
Location: Boon Lay
Job Description:
• 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.
Job Requirements: Min Degree in Life Sciences or similar w min 3 yrs of relevant experience in Records management experience in a GCP-regulated environment & food manufacturing industry. Experience in clinical trials in Nutrition is an advantage
Interested candidates, please submit your resume to: [email protected]
Ally Audrey Lok Xin Woon
Recruit Express Pte Ltd (Healthcare & Lifescience)
Company EA Licence number : 99C4599
Personnel EA License: R21102307
