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Clinical Project Manager
SAN FRANCISCO CA 94103
Category: Other
  • Your pay will be discussed at your interview

Job code: lhw-e0-90672871

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VIVA USA Inc

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Summary

  Job posted:   Thu Jun 7, 2018
  Distance to work:   ? miles
       
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Clinical Project Manager
Req Ref No: SGCACP5-38
Location: San Francisco, CA
Duration: 11.5 Months
Description
Description:
Sr. Clinical Data Manager
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)
VIVA is an equal opportunity employer. All qualified applicants have an equal opportunity for placement, and all employees have an equal opportunity to develop on the job. This means that VIVA will not discriminate against any employee or qualified applicant on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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