Senior Manager, Clinical Data Systems
About The Position
Tango has an exciting new opportunity to join the Biometrics team as Sr. Manager, Clinical Data Systems. In this role you will report to the Vice President, Data Management. You will be a subject matter expert at Centralized Imaging, electronic Clinical Outcome Assessments (eCOA) and other clinical technologies from study start up through data generation, decommissioning, and documentation archival. Clinical technologies will encompass a spectrum of systems including but not limited to eCOA, IRT and Centralized imaging. This position will enable clinical data management and support clinical data issue resolution for these technologies, ensuring high-quality clinical data to support key initiatives. You will be forward-thinking about the needs of a clinical development operations organization and possess high attention to detail. You will maintain a collaborative outlook with the ability to pursue multiple options in parallel.
Requirements
- 7+ years of clinical systems experience in the pharmaceutical or biotech industry
- Bachelor’s degree in a science-based subject (advanced degree preferred)
- eCOA and/or Centralized Imaging Subject Matter Expertise with an in depth understanding of clinical development process and regulatory frameworks governing solutions
- Hands-on Data Management experience of EDC, eCOA, IRT and Centralized imaging
- Experience with user requirement specifications/user test scripts with clinical data technologies
- Prior demonstration of creative, capable problem solving and innovation as it relates to integrations between clinical systems (eCOA, IRT, EDC, etc.) in a clinical research environment
- Prior engagement in activities that involve system development lifecycle to support the use of clinical technologies within a clinical study
- Ability to deal with time demands, incomplete information and prioritize tasks
- Technical excellence and solid technical skills across data platforms
- Working knowledge of ICH, GAMP, FDA, IRB/IEC and other applicable regulations/guidelines and demonstrated understanding of clinical research protocol requirements and appropriate reporting of clinical trial data
- Ability to work independently with a high level of attention and act with initiative to address issues
- Flexible, team-oriented, ability to manage multiple projects in a fast-paced environment
- Strong project management
- Excellent written and oral communication skills
- Demonstrated proficiency with MS Office, such as Outlook, Word, Excel, PowerPoint, and SharePoint
Responsibilities
- Serve as the Central Imaging, eCOA and clinical technologies Subject Matter Expert for Tango’s clinical studies and programs
- Lead clinical technologies including planning, execution, and delivery of the clinical data activities on Centralized Imaging, eCOA and clinical technologies, implementing secure procedures to initiate best practices and lead data management flow
- Demonstrate strong technical expertise to maintain high standards of data integrity, accuracy, reliability, efficiency and compliance with regulatory requirements
- Partnering closely with Clinical Data Management and Clinical Operations, assist with documentation and oversight of clinical data quality and timeliness such as tracking, KPIs, data management and monitoring
- Lead cross-functional collaboration to gather requirements, design systems, and deliver technology solutions on time, ensuring data quality and compliance standards are consistently met.
- Responsible for implementation project management, including clinical data systems integrations with EDC and reporting systems. Aid in device management as needed
- Oversee facilitation of clinical technologies technical support, data changes, data issue resolution; working with cross-functional stakeholders including Clinical Data Management, Clinical Operations and Biostatistics in order to achieve goals
- Responsible for user acceptance testing oversight and documentation, including UAT test case creation, facilitating signatures on documentation, and risk and impact assessment
- Responsible for the administration and uploading of documentation to appropriate eTMF
- Enable and guide study teams by delivering exceptional customer service and technical support for daily use of clinical systems.
- May assist with process updates, cross-functional initiatives, standards documentation updates, and/or SOPs
- Support inspection readiness activities as needed
- Additional duties and responsibilities as required
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What This Job Offers
Job Type
Full-time
Career Level
Manager
