Medical Consistency and Data Integrity Manager
3 dni temu
Job Description
The Oncology Clinical Trial Specialist will be responsible for performing medical review activities across multiple oncology studies with a wide range of therapeutic modalities and tumor types.
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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