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Job Function:

Non-Standard

Job Sub Function:

Non-Employee

Job Category:

Non-Standard

All Job Posting Locations:

Shanghai, China

Job Description:

Position Description:

As a key contributor to the clinical biomarker and diagnostic strategy, the Biomarker and Diagnostics Operations Associate/Associate Manager/Manager (Contractor) is accountable for implementation and execution of clinical sample management, testing and data delivery activities for both early and later phase clinical programs in oncology. This role should have the experience bridging both science and operations through cross functional partnerships, strategic project planning and facilitating key biomarker and diagnostic execution discussions.

Key Responsibilities:

• Drives the implementation and execution of the clinical biomarker and diagnostic strategy for clinical programs in early and late-stage oncology, align with the Global team to enable seamless operations of Chinese studies. Creates and manages biomarker and diagnostic plan, timelines, budget, risk assessments and quality metrics during study startup, conduct and closeout

• Works effectively with scientific leads, procurement, contracting team and compliance team to evaluate vendor capability and certificate, and prepare contracts and statement of work; oversee the contract execute status and ensure the delivery meet program requirements.

• Makes joint effort with Clinical Operation for HGR application for both molecular eligibility screening and exploratory biomarker.

• Timely monitors sample/data collection being under HGR approval throughout the study. Coordinates internal and external parties for regular or unscheduled HGR audits.

• Supports clinical operation and biomarker central lab for site staff training and refreshes sample requirement from central lab.

• Leads central lab setup and management throughout the course of a study, works as a bridge between central lab and internal stakeholders and maintains good relationships with internal and external partners.

• Manages relationships with specialty testing vendors to ensure biomarker/diagnostic samples are processed, tested and data is reported to meet development timelines and specifications

• Works closely with data management to establish data collection and transfer specifications with testing vendors and local labs

• Contributes to the preparation of clinical documents such as lab report template, lab manuals, informed consent forms, eCRF, sample/data management plan, early development plans and site training materials

• Works with scientific stakeholders to identify innovative bio-sample collection and processing techniques and ensures methods are implemented appropriately across clinical sites to the highest of standards

• Develops presentations and presents sample tracking/testing metrics at regular team meetings

• Supports scientific stakeholders to evaluate and implement new assays and relevant technologies as required by the program

• Participates and make TR/CDx operation update in cross-functions study team meetings across clinical, translational research and diagnostics.

• Supports scientific leads to find central testing issues, provide efficient solutions from operation perspective.

Qualifications:

• Life Science degree (M.S. minimum) in scientific, medical or healthcare area required. Additional qualifications: e.g., PhD and/or project management certification desirable.

• Relevant work experience in a clinical development, diagnostics and/or pharmaceutical/biotech R&D preferred

• Good knowledge and understanding of clinical drug development strategic planning of clinical research, ICF, ICH, GCP, GLP is preferred

• Project management experience is preferred

• Knowledge of oncology drug development and/or biomarker/diagnostic development is preferred

• Excellent written and verbal communication skills in both Chinese and English (CET-6)

• Ability to effectively and collaboratively work with global cross-functional teams

• Good soft skills and interpersonal skills

• Capability of good handling of complex projects and situations

Required Skills:

Preferred Skills: