Clinical data management manager

Clinical data management, rave, clinical trials
Contract Corp-To-Corp, Contract Independent, Contract W2, C2H Corp-To-Corp, C2H Independent, C2H W2, 12 Months
Depends On Experience
Telecommuting not available Travel not required

Job Description

Title: Clinical Project Manager

Location: San Francisco, CA

Duration: 12 Months +

 

Locals Preferred

 

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)

 

 

Thanks and Regards,

 

Sid

Dynamic Enterprise Solutions Inc,

Phone: 847-719-7907/224-927-9108 (cell)

Email ID: sid@dynamic-enterprise.net

URL: www.dynamic-enterprise.net

Dice Id : 10450168
Position Id : 2038
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