Clinician - FSP, Shanghai

Clinician

Role Summary:

Be responsible for high quality and timely delivery of one or more interventional clinical trials for a Global Product Development. They apply technical excellence in the design of cost-efficient clinical trials to meet the needs of internal and external customers, ensure effective conduct and medical/scientific oversight of studies (in partnership with Development Operations) and support appropriate interpretation and communication of clinical trial data (including high quality regulatory submissions and product defense activities). They ensure compliance with internal and external standards, proactively mitigate risk and manage emerging clinical issues.

The China Clinician may act as a site liaison and point of contact to expedite study start-up and conduct and to support clinical training, compliance and overall study quality.

Responsibilities:

Clinical Trials

• Co-chairs clinical study team and works collaboratively with other study team members.
• Point of accountability to the BU for design, conduct, interpretation and reporting of one or more clinical studies (or elements of those studies).
• Provides clinical and scientific expertise to the clinical trial strategy and protocol development process, including acquisition of knowledge of competitor products.
• Through application of Enhanced Clinical Trial Design (ECTD)/ Enhanced Quantitative Drug Development (EQDD), ensures the most efficient clinical protocols are developed.
• Designs/writes clinical trial outlines, protocols and amendments, in collaboration with internal contributors (e.g. statisticians, Outcomes  Research(OR) specialists, clinical pharmacologists, clinical project managers, Regional Clinical Site Leads (RCSLs), market access colleagues, commercial development colleagues), internal experts (e.g. clinical program lead, global clinical lead, global clinical strategy lead), and external experts (e.g. investigators, key opinion leaders, advisory board members); ensures design is consistent with objectives.
• Proactive in authoring efficient protocols that minimize the likelihood of amendments. Identifies and assesses study risks to good clinical practices, subject rights/safety and data integrity throughout protocol development and study conduct; creates, implements and assesses effectiveness of mitigation plans.
• Provides clinical input to Study Team for monitoring guidelines, iqRAMP, statistical analysis plans, informed consent documents, clinical review forms, data edit checks, data quality planning, Regional Medical Monitor - Medical Oversight Plan as needed (ultimately oversees work of Study Team).
• Contributes to CRO / vendor selection to ensure study is conducted consistent with protocol requirements, clinical plan expectations, and study timelines; this includes ensuring medical/technical requirements for data integrity are applied (e.g. lab specifications).
• Approves selection of countries, clinical sites and investigators with appropriate qualifications, patient populations, and recruitment strategy to meet goals in a timely, high quality and cost-effective manner.
• Ensures study is registered on www.ClinicalTrials.gov, study details are kept up-to-date and basic results are disclosed as required.
• Creates (and where appropriate, delivers) clinical/protocol training materials for study and site management and for use during site initiation visits and investigator meetings.
• Helps establish and oversees Data Monitoring Committees (DMCs) and endpoint adjudication committees, including chartering, contracts, provision of relevant data and documentation of outcomes.
• Jointly accountable with study team for study enrolment and adherence to agreed timelines for study deliverables.
• Maintains direct contact with investigative sites through site visits, telephone contacts, email etc., in order to facilitate investigator engagement, address investigator questions regarding the protocol or the investigational product, and support enrolment activities. This is done in conjunction with RCSLs (when assigned) for sites outside US, Canada, Japan and China. For some studies the clinician may take on an expanded role as described below for the site liaison responsibilities.
• Consistent with Safety Review Plan (SRP), performs and documents regular review of individual subject safety data and cumulative safety data with the safety risk lead (as delegated by the China Clinical Program Lead or the Global Clinical Lead). For all studies, clinical safety review should be performed in consultation with designated medically-qualified Medical Monitor.
• Responsible for identifying emerging safety trends and raising them forward for further discussion with the Clinical Program Lead and/or Global Clinical Lead; follows up with investigators for specific safety   findings (e.g. SAEs).
• Reviews and manages protocol deviations.
• Works with study team to ensure high quality of data, e.g. appropriate patient population, adequacy of clinical assessments etc., as study is ongoing.

Education

• Required: M.D., Ph.D., or equivalent qualifications with medical or public health background. Postgraduate training/certification /fellowship in a medical discipline or in drug development. Demonstrated scientific productivity (e.g. doctoral thesis, publications, research reports, etc.).