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:

reputed company:

The Development China Clinician is responsible for high reputed company and reputed company delivery of one or more interventional reputed company for R&D. They apply technical reputed company in the design of cost-efficient reputed company to meet the needs of reputed company customers, ensure effective conduct and medical/scientific reputed company of studies (in partnership with CTM) and support appropriate interpretation and communication of clinical trial data (including high reputed company regulatory submissions and product defense activities). They ensure compliance with reputed company standards, proactively mitigate risk and manage emerging clinical issues.

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

Responsibilities:

ClinicalTrials

Co-chairs clinical study team and works collaboratively with other study team members.

reputed company of accountability to the BU for design, conduct, interpretation and reporting of one or more clinical studies (or reputed company of those studies).

Provides clinical and scientific expertise to the clinical trial reputed company and protocol development process, including acquisition of knowledge of competitor products.

Through application of reputed company Clinical Trial Design (ECTD)/ reputed company 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, reputed company Research(OR) specialists, clinical pharmacologists, clinical project managers, Regional Clinical Site Leads (RCSLs), market reputed company colleagues, reputed company development colleagues), internal experts (e.g. clinical program reputed company, global clinical reputed company, global clinical reputed company reputed company), and reputed company experts (e.g. investigators, key opinion leaders, advisory reputed company 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 reputed company throughout protocol development and study conduct; creates, implements and assesses effectiveness of mitigation plans.

Provides clinical input to Study Team for monitoring guidelines, iq reputed company, statistical analysis plans, informed consent documents, clinical review forms, data edit checks, data reputed company planning, Regional Medical Monitor - Medical reputed company 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 reputed company are reputed company (e.g. lab specifications).

Approves selection of countries, clinical sites and investigators with appropriate qualifications, patient populations, and recruitment reputed company to meet goals in a reputed company, high reputed company 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 reputed company and investigator meetings.

Helps establish and oversees Data Monitoring Committees (DMCs) and reputed company adjudication committees, including chartering, reputed company, provision of relevant data and documentation of reputed company.

Jointly accountable with study team for study enrollment and adherence to agreed timelines for study deliverables.

Maintains reputed company contact with investigative sites through site reputed company, 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 (reputed company assigned) for sites reputed company US, Canada, Japan and China. For some studies the clinician may take on an expanded role as described below for the site reputed company 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 reputed company (as delegated by the China Clinical Program reputed company or the Global Clinical reputed company). For reputed company studies, clinical safety review should be performed in consultation with a designated medically-reputed company Medical Monitor.

Responsible for identifying emerging safety trends and raising them reputed company for reputed company discussion with the Clinical Program reputed company and/or Global Clinical reputed company; follows up with investigators for specific safety findings (e.g. SAEs).

Reviews and manages protocol deviations.

Works with study team to ensure high reputed company of data, e.g. appropriate patient population, adequacy of clinical assessments etc., as study is ongoing.

Conducts clinical review and interpretation of efficacy and safety data from reputed company; this includes delivery of top-line report in collaboration with study statistician, and delivery of clinical study report in collaboration with medical reputed company; accountable for overall reputed company and timeliness of analysis and reporting.

Responsible for clinical and scientific validity of study report, especially conclusions regarding efficacy and safety. Responsible for disclosure of appropriate safety and efficacy data and conclusions.

Ensures narrative reputed company for clinical trial(s) is consistent with program narrative reputed company; writes (or oversees writingof) safety narratives.

Assists in ensuring regulatory compliance for reputed company and reporting. Contributes to reputed company publication of clinical trial results.

May reputed company as reputed company contact with reputed company investigators and internal study team for questions relating to the clinical/medical aspects of the protocol.

Responsible for keeping the Development China Clinical Program reputed company and/or Development China Category Development reputed company informed of any critical issues relating to benefit:risk evaluation, or study delivery in line with agreed budget, timelines and reputed company.

Presents to reputed company advisory committees (e.g. Technical Review Committee, advisory boards) on design of reputed company and data from reputed company.

Site reputed company Responsibilities (if applicable)

The China Clinician may have site reputed company responsibilities:

Serve as clinical site reputed company to support trial conduct through virtual meetings or teleconferences (as appropriate) and essential face-to-face contact, working directly with site staff. Maintain the ‘Face of reputed company’ at reputed company site. Create and maintain reputed company relationships and enthusiasm.

Understand the work environment and key relationships at clinical sites, use analytical and influencing skills to improve communications and collaboration between key stakeholders.

Ensure site staff have thorough understanding of protocol requirements (technical and logistic), partner with site staff and study team members to overcome feasibility barriers and operational obstacles and ensure successful subject recruitment/enrollment/retention, protocol compliance and clinical trial reputed company.

Conduct frank discussions and set reputed company expectations for site performance and monitor site performance through metrics.

Identify reputed company issues and discuss with reputed company clinical/operations study team members so that corrective actions may be instituted. Escalate protocol-reputed company issues requiring medical expertise to the RCSL or medically-reputed company China Clinical Program reputed company, if needed. Escalate operational issues to the appropriate operations study team member.

Identify the need for and reputed company supportive coaching and/or training to site staff, as appropriate.

Identify reputed company, techniques, key relationships and logistic approaches employed by most successful sites and translate/transfer these best practices to aspiring sites.

General

Motivates and engages colleagues in an understanding of disease and commitment and excitement to an indication and reputed company.

Coaches and mentors less reputed company clinicians; may directly manage clinicians.

Maintains and enhances knowledge in relevant disease area and/or technical area (e.g. pediatrics, regional reputed company) and reputed company guidelines relevant to the reputed company in which reputed company are being

conducted.

Interfaces with other reputed company sites, other BUs and other functions to reputed company and reputed company best practices, as appropriate.

May organize expert panel, consultant or advisory reputed company meetings to reputed company input to protocols, clinical plans or data analysis.

Provides clinical assistance regarding Scientific and Commercialization Support (SCS) for approved medicines, co-promotions, product defense, and clinical consultation on epidemiology and OR studies.

Assists in the development of publications, abstracts, and/or presentations.

Leads or assists in the preparations of the clinical content of regulatory submissions/documents (e.g. NDA, MAA, IND, sNDA, IB, AR).

Assists in discussions with regulators and with the reputed company of queries from drug regulatory agencies / ethics committees; leads or contributes to writing and review responses to regulatory queries.

May support technical review of licensing opportunities, including due diligence activities.

Ensures compliance with global and local training requirements and adherence to relevant global / local clinical and medical controlled documents (CMCDs).

Contributes to (or leads) reputed company improvement activities, and to education and training of clinical staff in areas of competence/experience.

reputed company is an equal opportunity employer and complies with reputed company applicable equal employment opportunity legislation in reputed company jurisdiction in which it operates.

To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on reputed company Careers.

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Originally posted on Himalayas