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Job Details

Location
Shanghai
Salary
Depending on fit to requirements.
Job Type
Permanent
Ref
BH-160865
Contact
Gilbert Khor
Contact email
Email Gilbert
Contact phone
65 6692 0742
Posted
5 months ago
Based in China
Clinical Trial Development
Reputable MNC


The position will require the incumbent to be required for the development and executing of late stage trials (Phase II – IIIA) clinical strategies and plans that deliver medically-differentiated therapies that provide meaningful improvement to patients.  The Clinical Scientist will participate in the development of Clinical Trial Application, protocol development, study execution for the assigned molecule(s)/indication(s) and NDA filing. Working together collaboratively with other cross functional team such as the Medical Monitor (MM) developing their knowledge of clinical studies and the pharma/biotech industry. 

Responsibilities:

Cross-Functional Team Membership 
  • Participates in the team relevant to assigned molecule/ therapy and support the MM and SMT to enable effective and efficient CD plan execution
  • As requested, supports the Clinical Sub Team (CST) lead and overall team with  training new SMT members
Clinical Development Plan Implementation 
  • Provides clinical support across all relevant studies and programs:
      • Assistant MM for clinical science related working, including but not limited as follows
        • Participates in ongoing SMT/CST and relevant sub-team meetings
        • Designs and develops clinical studies for review and discussion with other CST members
        • Participates in  investigator and other external presentations, meetings and other communications
        • May support clinical operations, clinical research organizations (CROs), etc. by assisting MM for questions, other communications, and interactions
        • Conducts ongoing data review of medical/safety data for assigned studies
        • Supports, as needed, completion of interim study reporting and DBL for final reporting
        • Works with other SMT/CST members, regulatory and other internal partners/stakeholders in the completion and submission of regulatory filings and other regulatory documentation.
  • Develops presentations for other SMT/CST members
  • Completes other special projects, as and when assigned, or otherwise requested 
  • Consistently complies with all governing laws, regulations, Standard Operating Procedures (SOPs) and other guidelines

Qualification and Experience: 
  • PhD or M.D. with basic medical knowledge or relevant working experience
  • Some experience working as clinical scientist in industry, hematology experience is a plus
  • Some experience working with the principles and techniques for data monitoring
  • Understanding of  medical aspects of GCP, ICH guidelines
  • Outstanding attention-to-detail
  • Has working knowledge of the multi-disciplinary functions involved in a drug development process, e.g. clinical operations, biostatistics, data management, etc.
  • Excellent project management skills: can prioritize multiple tasks and goals and ensure the timely, on-target and within-budget accomplishment of such
  • Works well within teams and is effective in collaborating with others internally

Reg No.: R1443092
EBC Connect Pte Ltd
EA Licence: 17C8975