Senior/Principle Clinical Scientist
Internship Shanghai, CHINA Design / Civil engineering / Industrial engineering
Job description
· Job facts
Primary Responsibilities and Accountabilities
· Key-person in RICS to connect to clinical and development project teams in pRED Neuroscience and Rare Diseases (NRD)
· Develops plans to implement clinical trials in NRD at sites in China in line with the global project strategy
· Connects external hospitals and physicians with global and local clinical teams
· In collaboration with the global clinical team supports 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) in China
· Participates in development of the China 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 global project team members and relevant sub-teams to develop China CD plan components (e.g., analytics/data strategy, KOL development, publications strategy, etc.)
· Works with global project teams and other relevant teams to develop and provide information and input for budget/resource requirements necessary to implement and execute the China CD plan
· Assists in the management of China studies and supports the training and science input to clinical operation colleagues and study site staff
· Serves as trouble-shooter and internal key contact on clinical and medical issues and aspects of assigned studies in China; May support clinical operations, clinical research organizations (CROs), etc. by acting as a point-of-contact for questions, other communications, and interactions in China
· Provides clinical scientific input for final study reports and annual report documentation
· Supports safety representatives in the serious adverse events reporting process
· Represents China clinical science in study management and clinical teams
· Gives input to and reviews clinical regulatory documents (clinical study reports, investigator's brochure, safety reports, submission to health authorities)
· Assists in preparing materials for use in internal and external presentations (e.g. advisory board meetings)
· Supports global project team in preparing for HA meetings. As appropriate, participates in local HA meetings.
· Able to ethically, effectively and professionally represent 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
· Possible extension of contribution to other therapeutic areas beyond NRD
Qualifications and experience
· PhD-/MD-/PharmD-level (or equivalent relevant experience)
· Clinical research experience in neurological, neuropsychiatric, or rare diseases is strongly preferred
· >2 years of experience in clinical research
· Ability to acquire knowledge in different diseases and therapeutic areas
· Ability to work independently
· 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 great team player with good communication skills
· Fluent in English
· Ability to travel nationally, regionally, and/or internationally (<30%)
Roche is an equal opportunity employer.
Research & Development, Research & Development > Clinical Operations
· Who we are
At Roche, 98,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.
Roche is an equal opportunity employer.