Clinical Development Medical Review Expert

2 dni temu


Warszawa, Mazovia, Polska GlaxoSmithKline Pełny etat

Job Summary

We are seeking a skilled Clinical Development Medical Review Expert to join our team. As a key member of the Oncology Clinical Development organization, you will be responsible for ensuring the medical consistency and integrity of clinical data.

Main Responsibilities

  • Data Review and Interpretation: Responsible for reviewing and interpreting clinical data to ensure accuracy and completeness.

  • Collaboration with Cross-Functional Teams: Collaborate with Centralized Monitoring, Data Management, and Clinical Development teams to identify key study risks and develop strategies to mitigate them.

  • Medical Review Planning: Develop and execute medical review plans for studies, including defining the scope of the review and timelines.

  • Protocol Deviation and Query Resolution: Accountable for reviewing protocol deviations and medical queries, and working with site teams to resolve these issues.

  • Trend Analysis and Reporting: Conduct trend analysis and provide reports on data inconsistencies and other findings to support quality improvement initiatives.

Requirements

  • Bachelor's degree in Life Science or related field with 5+ years of industry experience or relevant clinical experience.

  • Experience with data review/interpretation, study design, and clinical development processes.

  • Knowledge of Good Clinical Practice principles and electronic data capture systems.

  • Excellent communication and presentation skills.

  • Able to work productively in a fast-paced collaborative team environment.



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