Clinical Research Lead

3 weeks ago


Shanghai, Shanghai, China Roche Full time

Job Summary

The Clinical Research Expert/Lead will play a key role in supporting the registration of Roche Diagnostic China products globally. This includes clinical software, instrument platforms, assays, reagents, devices, instruments, systems, and biomarkers. The ideal candidate will be a team player who can foster cross-functional relationships and create a collaborative work environment.

Main Responsibilities

  1. Participate in cross-functional project teams to support clinical research activities.
  2. Ensure alignment across studies and lifecycle teams with current regulatory expectations.
  3. Be the expert and scientist in diagnosis and treatment, skilled in protocol design.
  4. Identify opportunities to simplify and speed up the institution, EC, and HGRAC application process.
  5. Develop and maintain test materials and equipment management plans.
  6. Provide technical expertise to staff for feasibility assessment review and the development of clinical trial documents.

Key Requirements

  1. Regulatory compliance expertise.
  2. Strong communication and collaboration skills.
  3. Ability to manage multiple projects and priorities.
  4. Experience with clinical trial design and implementation.
  5. Knowledge of clinical software, instrument platforms, assays, reagents, devices, instruments, systems, and biomarkers.


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