[Innovative Medicine]Lead Clinical Science Oncology Biomarker Operations(Contractor)

Johnson & Johnson

4.2

(92)

Shanghai, China

Why you should apply for a job to Johnson & Johnson:

  • Ranked as one of the Best Companies for Women in 2020
  • 4.2/5 in overall job satisfaction
  • 4.2/5 in supportive management
  • 71% say women are treated fairly and equally to men
  • 88% would recommend this company to other women
  • 85% say the CEO supports gender diversity
  • Ratings are based on anonymous reviews by Fairygodboss members.
  • Global parental leave for all new parents (maternal, paternal, adoptive or surrogacy-assisted).
  • Global exercise reimbursement.
  • Two weeks off (one of them fully paid) for volunteer work.
  • #2406227216W

    Position summary

    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

    Why you should apply for a job to Johnson & Johnson:

  • Ranked as one of the Best Companies for Women in 2020
  • 4.2/5 in overall job satisfaction
  • 4.2/5 in supportive management
  • 71% say women are treated fairly and equally to men
  • 88% would recommend this company to other women
  • 85% say the CEO supports gender diversity
  • Ratings are based on anonymous reviews by Fairygodboss members.
  • Global parental leave for all new parents (maternal, paternal, adoptive or surrogacy-assisted).
  • Global exercise reimbursement.
  • Two weeks off (one of them fully paid) for volunteer work.