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Offers “Roche”

days ago 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%)

Research & Development、 Research & Development > Clinical Operations

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