TRANSCENTA HOLDING - A Global Fully Integrated Biotherapeutics Company

Transcenta, Biologics, Antibody, Claudin 18.2

TRANSCENTA HOLDING - A Global Fully Integrated Biotherapeutics Company

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Manager,Clinical Trial

Manager,Clinical Trial

Global R&D
Working place :  Beijing
Recruitment :  1
Nature of work :  Full-Time
Working years of :  >3 Years
Minimum academic :  Bachelor Degree And Above
Release time :  23 Aug, 2020
Job Responsibilities
  • Fully responsible for clinical research project management and monitoring of project operation, quality, budget, and time plan;

  • According to the clinical trial plan, responsible for formulating the work plan and budget, forming a project team, and coordinating the team and various departments to confirm the work plan;

  • Cooperate with CRO to conduct project feasibility survey, screening of test center, determination of main researchers and participating researchers, and preparation and convening of project launch meeting

  • Review the clinical research contract of each center and guide CRA to complete the negotiation and signing of the research contract with each center;

  • Formulate risk assessment and management plan; assist CRA to develop audit plan;

  • Coordinate preparations for project verification and cooperate with on-site verification of clinical research;

  • Assist the Ministry of Medicine and other relevant departments to complete the statistical analysis report and summary report of clinical trials;

  • Assist other tasks assigned by superior leaders

Job Requirements
  • Bachelor degree or above in medicine, pharmacy or related majors;

  • More than 3 years of clinical experience, more than 1 year of study / project management work experience, tumor experience is preferred;

  • Familiar with GCP and clinical related SOP;

  • Have excellent team organization skills and project management skills, such as organizing a project team meeting, if problems arise, they can respond quickly and come up with solutions

  • Good communication and writing skills;

  • Proficient in using computer and office software; English level 6 or above;

  • Have a positive working attitude, independent working ability and good teamwork spirit.