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Job Descriptions

Clinical Data Management Assistant, Level 1

Position Summary

CRC Oncology is seeking for a Clinical Data Management Assistant will be responsible for providing quality management of clinical trial data in a rapidly evolving environment, meeting industry standards. The CDM will own the data management activities including Case Report Form (CRF) designing, database designing, oversight of CROs data managers and developing Data Management Plan, CRF annotation, implementing edit check programs, data entry and query status tracking, and database closure. The CDM is responsible for ensuring compliance with the corporate timelines and scope of work. The CDM is also responsible for leading or supporting company process improvement initiatives.

Responsibilities

• Support the clinical study team by helping to implement standards for Data Capture and safety data, assessing the overall quality of data and identifying and advancing key data issues, trends or patterns that may pose overall study compliance and/or data quality concerns, e.g., frequency of queries and protocol deviations
• Provide expertise to the standardization of Clinical Data Management processes and process improvement and efficiency
• Oversee the development of data validation specifications and programs for assuring the accuracy of clinical trial data, e.g., data review guidelines, computerized edit check programs, Data Management Plans (DMP)
• Coordinate the review of clinical data, analysis tables/listings/figures, and patient profiles for data consistency and accuracy
• Provide input to vendor and technology (e.g., EDC) evaluation, qualification and selection
• Work with the pharmacovigilance group to establish processes for reconciliation between the safety and clinical database on an ongoing basis
• Able to use clear judgment to tackle problems and to call out issues with proposed solutions, as necessary
• Must ensure SOP and regulatory compliance with FDA regulations, GCP, ICH guidelines and Good Clinical CDM Practices internally and with CDM vendors via regular process auditing
• Ensures CDM project documentation is in an inspection-ready state
• May need to provide input to RFP development and contract negotiation, as needed

Qualifications

• MS preferred, open to entry level and newly graduate candidates
• Must be bilingual (Fluent in English and Chinese)
• Professional, proactive demeanor
• Strong interpersonal skills
• Excellent written and verbal communication skills
• Experience with people management and development of staff
• Excellent interpersonal and project management skills
• Comprehensive knowledge of clinical trials methodology (experience with Bayesian methods preferred), regulatory requirements, and statistical software packages. Experience with interventional, observational and retrospective studies. Ability to contribute strategically
• Able to collaborate effectively with internal and external study management teams to meet project timelines
• Must be solution-oriented and willing to educate study team members in appropriate interpretation of designs and results

Employment Type

Full-time