Clinical Research Associate

  • Location

    Singapore

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Salary:

    S$5000 - S$6000 per month

  • Contact:

    Abhik Damani

  • Contact email:

    abhik.damani@voltasia.com.sg

  • Job ref:

    BBBH8844_1610518201

  • Published:

    9 months ago

  • Expiry date:

    2021-02-12

My client is a leading player in the medical device industry and now seeks an experienced Clinical Research Associate

  • Leading Name
  • Excellent Products
  • High Salary

Responsibilities:

  • Assume responsibility for management of clinical operations at trial and site level
  • Develop clinical strategy for products in coordination with regulatory and marketing strategies.
  • Manage vendor and CRO activities and track internal and external project deliverables
  • Participate in clinical research activities and assist in management of clinical study sites, management of study documentation, and completion of project management tasks.
  • Prepare and maintain Clinical Study Files - Trial Master Files, Investigator Site File, Investigator File, study essential documents and regulatory documents
  • Work with CRO to prepare Ethics committee document for submission and other tools, templates and documents before clinical site initiation.
  • Develop clinical trial timelines, enrolment projections, documents and instructional materials, including project management, monitoring, recruitment, and risk management
  • Support Post-Market Clinical Follow-up and clinical vigilance reporting and internal investigation
  • Support annual updating of Clinical Evaluation Report evaluation report for commercialised devices devices.
  • Maintain effective working relationships with investigators/investigational site research coordinators, and vendors including core labs, data management, and CROs.
  • Upload cases and enter biometrics for assigned clinical studies
  • Liaise closely with a multidisciplinary team to coordinate pilot production of new products

Requirements:

  • Degree in Biology, Life Sciences, Biotechnology or equivalent
  • At least 3 years of clinical affairs experience
  • Experience in registry studies and investigator-initiated studies will be preferred
  • Familiarity with medical device regulations MDR, quality management system (ISO 13485), (21 CFR Part 820), and other medical ISO standards
  • Occasional travel to conduct site visits/vendor audits etc.

Please send your resume in WORD format by clicking the apply button below or contact Abhik Damani on +65 6701 1527 for a confidential discussion. Please note that only short-listed candidates will be contacted. CEI Reg. Number R1544061 (Abhik Damani).