Clinical Data Manager

Summary

The Clinical Data Manager will be responsible for providing leadership and oversight of data management activities on multiple Bioatla’s clinical trials to ensure accuracy and consistency of Clinical Data for subsequent analysis and reporting.

Position is in San Diego, CA. Remote work option is available.

Essential Duties and Responsibilities

• Serve as the Bioatla project lead DM on multiple trials and ensure data collected on trials meets the requirements of the study objectives and company quality standards.
• Oversee and lead vendor/CRO study data management team, including DM activities at database build, conduct and database lock. Participate in regular team meetings and oversee critical to quality activities, such as SAE reconciliation and critical data review.
• Provide technical expertise for the development of data management and other clinical trial documents (including Data Management Plans and associated documents, Protocols, Centralized Monitoring Plans, CRF Completion Guidelines, Data Transfer Agreements) and trial conduct.
• Participate in the design and user acceptance testing of clinical study databases to match protocol specifications.
• Ensure up-to-date and accurate tracking of ongoing assigned study data quality, proactively identifying and mitigating risks to support quality and timely data delivery at study or program related milestones.  
• Lead the internal cross functional team in the data review process, in support of high data quality on assigned studies.
• Develop and provide data listings, patient profiles, and other reports in support of data cleaning and development activities utilizing reporting tools such as JReview, SAS or R.
• Ensure that the Data Management component of the TMF and other documentation required to support regulatory submissions and inspections are maintained to the standard required
• Coordinate closely with Clinical Operations, Clinical Development, Biostatistics, Statistical Programming, Drug Safety, Project Management and Regulatory to ensure operational excellence.
• Participate in the development and implementation of standards and processes related to both Clinical Data and risk-based quality management of clinical trials.

Other Duties

• Travel: Estimated up to 20% of the time, U.S. and international.

Competencies & Experience

• Thorough knowledge of data management and its role in the drug development process
• Understanding of the contributions of other functions critical to the execution of clinical trials, and their interactions with data management
• Demonstrated proficiency with EDC systems such as Medidata Rave, Merative Zelta is required. Experience with JReview or other reporting tools is a plus.
• Thorough understanding of Good Clinical Practices, regulatory guidelines, and industry standards (e.g., ICH/FDA guidance, CDISC standards, GCDMP, 21CFR11 etc.) and their application to Data Management practice
• Working knowledge of Microsoft tools, e.g. Excel, Word, SharePoint
• Experience working with a globally distributed team
• Ability to work on and solve complex problems.
• Ability to prioritize and handle multiple tasks simultaneously.
• Excellent communication/interaction skills and experience in a dynamic and growing organization.

Education

• BA/BS required, preferably in the scientific/healthcare field.
• At least three years’ experience in Data Management for the pharmaceutical/biotechnology industry, or equivalent experience in an FDA-regulated environment.
• Experience and understanding of the oncology therapeutic area is preferred.

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