Clinical Trial Assistant (1 Year Contract ) - FMCG #HHL

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 [Confidential Information] or telegram me @alexgohhl

Alex Goh Hock Leong (Alvin)

Recruit Express Pte Ltd (Healthcare & Lifescience)

Company EA Licence number : 99C4599

Personnel EA License: R1763413