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Clinical Trial Assistant

Full-Time Singapore, Singapore
Health & Biotech
Health & Biotech
05 March 2025
Description
  • Set-up Trial country relevant documents
  • Create local signature page
  • Set-up share point, public drives, Microsoft teams, etc.
  • Enter feasibility tracking information to Client Clinical Trial Management System (CTMS)
  • File Site qualification follow up letter submission in Trial Master File (TMF) staging area
  • Support to Clinical Trial Manager (CTM) to inform Trial Documentation Service (TDS) about trial events to trigger document collections from sites
  • Support CTM with administrative aspects in managing the importation and release of Investigational supplies (communication and scheduling, obtain Import Licenses) (CTM to release green light, Clinical Research Organization (CRO) supposed to support all other administrative but if not covered by CRO, to be supported by CTA)
  • Support the coordination of Investigational non-drug supply with the Clinical Supplies (if not possible by CRO)
  • Co-ordinate translations of documents after review/translation (approvals, applications, advertising, patient materials, Informed Consent Forms (ICFs) etc.) and submit for TMF filing
  • Support for site contract preparation/negotiation/execution (CTM provides template, CRA responsible for site adaptation)
  • Update Client CTMS: add sites; site staff; event dates; ICF versions; applications; initiation checklists; update trial team members
  • Set up Paper Trial Master File if applicable
Qualifications
  • Ability to collaborate with internal team members/functional lines, CROs, vendors and sites
  • Good oral/written communication, organizational, interpersonal, and sound problem-solving skills
  • Advanced presentation skills
  • Sense of urgency in completing assigned tasks and ability to assist others to meet study/country deliverables and consistently performs high quality work
  • Strong computer skills including but not limited to the knowledge of a Clinical Trial Management System (CTMS), Electronic Document Management System (EDMS)
  • Able to multi-task under very limited direction, work independently and seek / receive guidance when necessary
  • Effective time management skills in order to meet study needs, team objectives and department goals
  • Proven ability to work across cultures
  • Ability to successfully work in a “virtual”team environment which may be matrixed organization
  • Proficient in written and spoken English language
  • Proficient in local language, as required

Knowledge And Experience

  • Site Management experience or equivalent experience in clinical research, with understanding of clinical trials methodology and terminology
  • Experienced in Microsoft Office Products (Word, Excel, PowerPoint, SharePoint, Teams) and other clinical trial systems (e.g., CTMS, electronic data capture and eTMF)

Education

  • Educated to degree level (biological science, pharmacy or other related discipline preferred)

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