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.
Qualifications:
- Bachelor's Degree in health care, life sciences or related field with demonstrable related experience in in Food/Pharma/CRO industry or in an academic setting
- Strong general administrative skills and a minimum of 2 years of clinical studies administration experience
TELE me at @renovatingmyhouse or WA me at NOW!
Interested candidates, please submit your resume to
Celine Liew
Outsourcing Team
Recruit Express Pte Ltd (EA Licence No.: 99C4599)
