What are the responsibilities and job description for the Senior Clinical Data Manager position at Pulmonx Corporation?
Pulmonx is looking for a Senior Clinical Data Manager to join our Clinical Affairs team. This role will be responsible for developing and implementing clinical data management (CDM) strategies, processes and standards for all phases and activities of our Pulmonx‘s clinical investigations. Our ideal candidate will have a depth of knowledge and experience with industry standards compliance and all applicable local and international regulations to ensure we have the highest quality data.
This is a remote opportunity for qualified candidates in the United States.
Essential Job Functions :
- Provide leadership, strategic planning, direction and implementation of clinical systems for data collection which may include vendor selection, budgeting, resource planning, vendor oversight, EDC build and study timelines, etc.
- Perform or provide oversight to staff for all CDM activities from study startup to archival : design CRFs / eCRFs, create Data Validation Specifications, Data Management Plans, eCRF Completion Guidelines, and Data Review Plans, code terms in MedDRA and WHODrug; and complete data base lock, archival, and closeout activities
- Develop and manage standard operation procedures (SOP and CLPs) for clinical investigation data management; Data Management Plans (DMP), eCRFs, user acceptance testing (UAT) plans and scripts; EDC build and associated edit checks
- Provide study level metrics / reports and external data reconciliation processes relating to CRF review, query status, data entry, monitoring status, management of independent review vendors, and any other relevant matters; translate metrics into performance assessment and opportunities
- Collaborate with cross-functional team and management to implement and govern CDM processes and standards to meet all applicable quality requirements and regulations, manage and oversee all phases of data management activities
- Provide program / study level oversight and expertise for CDM activities for multiple studies
- Review clinical data on an ongoing basis to ensure consistency, integrity and accuracy; assess and identify key data issues, trends or patterns that may pose overall study compliance and / or data quality concerns
- Establish external data reconciliation processes; develop CDM processes for management and determination of adjudication for independent review of video-endoscopies, CT scans
- Build and drive positive relationships and teamwork within the clinical team and partnering sites with professional demeanor
- Make decisions and chart course through careful evaluation of risks and benefits with limited information in conjunction with leadership; serve as the interdepartmental subject matter expert for the CDM area
- Evaluate and manage CROs and external technology vendors to meet company’s goals and clinical data management quality standards on an ongoing basis
- Assist with routine quality audits as applicable
This position requires periodic domestic travel (less than 10%)
Requirements :
Please note that an application and resume must be completed and submitted for consideration for this opportunity.
Pulmonx Corporation is an Equal Opportunity Employer and embraces diversity. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any characteristic protected by applicable law.
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