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Position Title:Physician/Senior Physician
Department:Clinical Development
Location:Shanghai

Position Summary

Support clinical development planning and execution to align with customer’s clinical trial project request and quality standard. By interacting with various key functions (for example clinical operation, biometrics, quality assurance and pharmacovigilance)。 This position will provide clinical expertise to conduct and manage project related medical monitoring. He/she shall deliver high quality clinical scientific services by providing medical input to protocol, contributing to protocol adaptation, conducting medical writing, and relevant activities. He / she shall also build and maintain good medical science relationships internally with all functional lines within the company and externally with KOLs and investigators. He / she will have the exposure to different project teams, diverse portfolio of clients, as well as various therapeutic areas.

Key Responsibilities

  • Assist clinical development planning and execution to serve the clients
  • Support to oversee clinical development activities in medical monitoring and medical writing
  • Play key role in providing medical and clinical inputs to the projects, as well as insight into the process.
  • Provide medical review and clinical input on clinical protocol design, protocol adaptation, and monitoring on clinical trial execution
  • Provide medical and scientific input of client’ inquires and discussion
  • Liaise with clients to support study design and site capabilities
  • Ensure the physical and mental wellbeing of subjects is undiminished during the study
  • Responsible for ensuring that the clinical trial is conducted per clinical development plan and all applicable regulations
  • Act as the primary client’s contact for medical and medical safety monitoring.
  • Contribute to medical writing on clinical study related documents, including IB, study synopsis, protocol, CSR or other relevant documents.
  • Perform literature searches as needed for drafting document content. Interprets literature information
  • Attend study initiation meetings; Liaise with clients regarding study design and site capabilities
  • Assist clinical operations and client managers with sponsor visits
  • Review pre-study physical examination and lab data to ensure subjects recruited to meet study inclusion exclusion criteria
  • Help to develop and administer budgets, resource plans and performance objectives for the clinical development function
  • To assist the training for junior staff, and colleagues regarding therapeutic area knowledge
  • Closely monitor relevant therapeutic area movement, clinical research updates and maintain sound medical and scientific capability.

  • Education and Key Competency Requirement
    Professional Experience & Education Requirement

  • Minimum M.D degree or other life science degrees (or equivalent); clinic practice is required
  • Minimum 4 years of experience as physician or medical manager in biopharmaceutical industry
  • Rich working experiences in medical monitoring
  • Rich working experiences in providing medical and scientific advices on clinical trial protocol design and other clinical development strategies

  • Key Competency Requirement

  • Ability to think critically and scientifically
  • Strong organizational, interpersonal, self-motivation, and high personal integrity
  • Ability to determine and prioritize workload
  • Ability to communicate professionally and courteously with clients
  • Proactively seeks out process improvements, efficiencies, and innovations
  • Well-developed of time management, communication, presentation, analytical and interpersonal skills
  • To have a detailed knowledge of the regulatory guidance for ICH/GCP
  • Strong though leadership contributing to project outcome
  • Facilitation and influence skills
  • Project management skills and effectively manage timeline and multiple tasks
  • A strategic thinker with strong problem Solving skills
  • Excellent English written and verbal communication skills
  • Proficient in the use of relevant office applications Experience in Oncology will be desired
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