1 Year Contract Clinical Trial Documentation Specialist #HJN

Key Responsibilities 1. Trial Master File (TMF/eTMF) Management • Set up, maintain and archive electronic Trial Master Files (eTMF), ensuring documents are accurately filed and approved. • Conduct filing quality checks (QC) to ensure completeness, accuracy and compliance with GCP and internal SOPs. • Develop eTMF guidelines and review processes to support CRO oversight. • Maintain clinical study documentation in accordance with regulatory requirements and internal procedures. 2. Clinical Trial & Project Administration • Provide administrative and operational support to Clinical Project Managers (CPMs) and study teams. • Maintain clinical study management tools, trackers and databases. • Assist with clinical trial registration on ClinicalTrials.gov. • Support study logistics, including sample and ancillary shipments, procurement of study supplies and training arrangements. 3. Budget & Invoice Management • Assist with clinical study budget monitoring and invoice management. • Coordinate vendor creation, goods receipt checks and payment processing. • Upload invoice information into the finance budget system. • Monitor monthly financial commitments and actual study expenditure. 4. Documentation & Quality Assurance • Review protocols, informed consent forms and advertisement materials for compliance with SOPs and regulatory requirements. • Assist in preparing, reviewing and maintaining SOPs, work instructions, training materials and templates. • Ensure clinical trial activities and documentation adhere to Good Clinical Practice (GCP) and applicable regulations. 5. Meetings & Stakeholder Coordination • Coordinate internal clinical meetings, CRO meetings and investigator meetings, including agendas, minutes and logistics. • Support global communications, including newsletters, emails and website updates. • Work closely with internal study teams, CROs and external stakeholders to ensure smooth clinical trial operations. 6. Process Improvement • Support continuous improvement initiatives involving clinical trial management systems (CTMS), SOP revisions and process enhancements. Employment Type: 1-Year Contract (Extendable) Salary: Up to $7,000 per month Bonus: 1-Month Completion Bonus Requirements • Minimum 2 years of relevant experience in clinical research or clinical trial operations, preferably within a pharmaceutical company or on the sponsor side. • Strong experience in Trial Master File (TMF/eTMF) management is highly preferred. • Familiarity with clinical trial documentation, filing QC and regulatory compliance. • Good understanding of Good Clinical Practice (GCP), ICH guidelines and clinical research SOPs. • Experience in clinical study coordination, CRO oversight or clinical project administration will be advantageous. • Exposure to clinical trial budget tracking, invoice management and CTMS is an added advantage. Janeve wa.me/6588183965 OR Email me at janeve.ng@recruitexpress.com.sg EA Personnel : Janeve Ng Choy Tong C.E.I: R25159176 Company Registration No: 99C4599 Recruit Express Pte Ltd