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Talentvis Singapore Pte Ltd

4.3
Website: http://www.talentvis.com Country: Singapore Sector: Consulting Size:

Clinical Project Manager - Full-Time

  • Employee must have a good understanding of the following:
  • Good Clinical Practices, ICH guidelines, PhRMA code, CFR Guidelines, clinical research ethics, HIPAA and patient privacy laws (plus applicable local regulations, when country-based),
  • Knowledge of concepts of clinical research and drug development, and
  • General therapeutic area education and training

Responsibilities

  • To be the single point of contact for company studies in regional clinical centres across Asia Pacific
  • To work closely within the team and other Project Managers to ensure the day-to-day implementation and monitoring of the clinical studies
  • To closely integrate into the clinical centre and engage in open communication with clinical investigators
  • Preparation of a weekly enrolment updates for Project Directors, CMO and CSO
  • To perform study feasibility & site evaluation visits with the CRO study monitor and Project Director
  • To review and approve the visit reports provided by the CRO study monitor
  • To perform co-monitoring visits to ensure the quality of clinical data
  • To negotiate with the clinical site in finalizing the study budget & clinical trial agreement
  • To ensure clinical studies are delivered to agreed budgets
  • To work closely with CROs to deliver to agreed project milestones
  • To work closely with clinical CROs to ensure that clinical protocols are clearly understood and correctly implemented and that data is logged in the agreed format

Requirements

Jasmine Choong | R11C5813
Talentvis Pte. Ltd | EA License: 04C3537

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