Offers “Roche”

Expires soon Roche

Clinical Scientist

  • Internship
  • Shanghai, CHINA
  • Design / Civil engineering / Industrial engineering

Job description



·  Job facts

Primary Responsibilities and Accountabilities

·  Key-person to connect to research and clinical project teams in pRED oncology
·  Develops plans to implement clinical trials in oncology
·  Possible extension of contribution to other therapeutic areas beyond oncology
·  Connects external hospitals and physicians with research and clinical teams
·  Lead development and writing of protocol and related documents, e.g. case report form (CRF), informed consent form(ICF), source document verification plan (SDV)
·  Key-contributor to response to questions from regulatory agency/institutional review boards (IRB)
·  Participates in development of the clinical development (CD) plan for assigned molecule(s)/indication(s) and/or other programs:
·  Gathers and analyzes data and information necessary to create the CD plan (particularly in China)
·  Works with other project members and relevant sub-teams to develop CD plan components (e.g., analytics/data strategy, KOL development, publications strategy, etc.)
·  Works with project teams and other relevant teams to develop and provide information and input for budget/resource requirements necessary to implement and execute the CD plan
·  Assist in the management of studies and support the training and science input to operation colleagues and study site staff; Acts as a medical monitor for assigned studies
·  Serve as trouble-shooter and internal key contact on clinical and medical issues and aspects of assigned studies; May support clinical operations, clinical research organizations (CROs), etc. by acting as a point-of-contact for questions, other communications, and interactions
·  Provide clinical scientific input for final study reports and annual report documentation
·  Support safety representatives in the serious adverse events reporting process
·  Represent translational medicine in study management teams and may represent translational medicine in clinical team meetings
·  Assist in the preparation of the clinical development plan
·  Give input to and reviews clinical regulatory documents (clinical study reports, investigator's brochure, safety reports, submission to health authorities)
·  Assist in preparing materials for use in internal and external presentations (e.g. advisory board meetings)
·  Supports project team in preparing for HA meetings. As appropriate, participates in HA meetings. Ethically, effectively and professionally represents the interests of Roche and patients
·  Consistently complies with all governing laws, regulations, Roche Standard Operating Procedures (SOPs) and other guidelines; Ensure GCP compliance in assigned pharma research and early development studies

Qualifications and experience

·  PhD-/MD-/PharmD-level (or equivalent relevant experience)
·  Clinical research experience in oncology is strongly preferred
·  >2 years of experience in clinical research
·  Ability to acquire knowledge in different diseases and therapeutic areas
·  Leadership skills, including motivating, delegating, coaching, and mentoring
·  Personnel managerial skills
·  Demonstrates and applies independent thought in projects
·  Effective scientific communicator
·  Recognized externally in own field
·  A team player with communication skills
·  Fluent in English
·  Ability to travel nationally, regionally, and/or internationally (<30%)

罗氏是一家提供均等机会的雇主。
Research & Development、 Research & Development > Clinical Operations

·  Who we are

在罗氏,来自100个国家的98,000名员工不断推动着健康医疗行业的进步。我们一同工作,使罗氏成为了世界领先的以研发为基础的健康医疗集团。我们的成功源于创新、求知和多元化,也源于我们把相互间的差异作为一种优势。为了革新医疗健康领域,罗氏设定了远大的计划,坚持学习和发展,并不断寻找与之志同道合的伙伴。

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