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 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).
- Supports organization of clinical meetings (internal meetings, meetings with CROs, Investigators meetings, etc.) including agenda, minutes, logistics.
Job Requirements:
- Bachelor's Degree in health care, life sciences or related field
- Good knowledge of Good Clinical Practices (GCP), regulations/guidelines and of the quality control process and compliance requirements in relation to TM
Interested candidates do attach your resume to
Attn: Angela Celeste Poh Li Ying (R2095367)
Recruit Express Pte Ltd (99C4599)
