Sr. Clinical Data Manager in San Francisco, CA at Apex Life Sciences

Date Posted: 7/11/2018

Job Snapshot

Job Description


Description:



As a Senior Clinical Data Manager you will be able to work independently and be accountable to set the priorities and ensure all data management procedures are executed with high attention to detail, accuracy and timeliness. The Senior Clinical Data Manager will work on multi-functional teams and will support CDM through experience and knowledge as a departmental subject matter expert. They will maintain program/project level perspective, focus and communicate effectively as the SME on data management issues, activities, and deliverables. 
Responsibilities: 

  • Serve as the data management subject matter expert on multidisciplinary clinical project teams providing specific expertise on timeline development and identification of data management deliverables and resource requirements 
  • Create, review, and maintain project timelines and monitor progress of data management activities 
  • Assist in the preparation and review of specifications for designing, monitoring and transferring of electronic databases 
  • Be a strong technical resource relative to CDM and CDM supportive tools, programming and reporting environments 
  • Assist in the development and implementation of the design and programming of clinical databases and data cleaning procedure 
  • Perform user acceptance testing on database applications and data transfers 
  • Create required study documentation (i.e. DMP, DVS and CRF Completion Guidelines) 
  • Review and approve CRF design, data review and database design guidelines according to Standard Operating Procedures and protocol specific requirements 
  • Review, analyze, and validate clinical trial data throughout the study lifecycle to ensure data consistency, integrity and accuracy based on project specific guidelines 
  • Query data inconsistencies and revise case report forms in compliance with standard operating procedures, client guidelines and regulatory agency guidelines 
  • Generate and review reports and listings to maintain data integrity and reporting 
  • Execute quality control activities such as preparing and carrying out internal database review, performing visual QC on data transfers 
  • Act as clinical data management liaison/lead to communicate study status, timeline updates, scope change with internal project management and departmental leadership 
  • Manage and/or liaise with 3rd party vendors specifically related to data collection, review and analysis, and communicate project timelines 
  • Perform external data reconciliation; assist in developing/designing reports and computer programs to assist in the data review process and provide operational metrics 
  • Develop strong working relationships and maintain effective communication with Clinical Operations, Safety Regulatory, Biostatistics, Programming, and Quality Assurance 
  • Assist in developing data management process and procedure improvements 
     

Requirements: 
 

  • Bachelor’s Degree in Life Science, Nursing, Computer Science or related disciplines or equivalent combination of experience and education 
  • 8+ years of experience in CDM, of which 3+ years in either a leadership role as a Team Leader/Manager for a significant clinical program, or a supervisorial role within a CDM function
  • Proficiency in the development and use of commercial clinical data management systems/EDC products (e.g. RAVE, Inform, TrialMaster, Oracle Clinical/RDC, etc.) 
  • Extensive clinical data management experience in Pharmaceutical or CRO setting 
  • Comprehension of medical terminology desirable 
  • Experience using relational databases (e.g. MS SQL Server, MS Access, or Oracle) 
  • Knowledge of clinical research, FDA & ICH, GCP, GCDMP, and related regulatory requirements 
  • Clinical Data Mgmt expertise; EDC expertise (experience with Rave is a plus); experience with Data Review tools (i.e. Spotfire, JReview) 
  • Flexibility to work remote 1-2 days a week after establishing themselves

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EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystemsinc.com or 844-463-6178.