Onco Clinician (Contractor)-Shanghai/Beijing

Job Title: Onco Clinician (Contractor)-Shanghai/Beijing

Job Location: China - Beijing - Beijing; China - Shanghai - STIT

Job Location Type: Remote

Job Contract Type: Full-time
Job Seniority Level:
Role Summary:

The Development China Clinician is responsible for high quality and timely delivery of one or more interventional clinical trials for R&D. 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 CTM) 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:

ClinicalTrials

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, iq RAMP, 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 enrollment and adherence to agreed timelines for study deliverables.

Maintains direct contact with investigative sites through site visi