• 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 and establishing review processes.
• 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 budget and invoice management: vendor creation, 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.
• Contributes to continuous improvement of working processes (for example supporting data entry into CTMS, SOP/SWI revision)

Requirements:

• min. Degree in any disciplines and above
• Possess min. 3-4 years prior working experience in clinical trial functions, preferably in a MNC environment
• Team player and able to work independently as well

Interested candidates, please forward your resume to [email protected]

Consultant: Jalene Tan (R26160390)
Recruit Express Pte Ltd (99C4599)