Clin DB Validation Analyst

Job Title / Primary Skill: Clin DB Validation Analyst

Years of Experience: 2-4 Years

Job Location: Bangalore

Must Have Skills: Clinical data management, data management, start up, Validation

Good To Have Skills: Rave

Job Description

• Conduct testing activities and provide comprehensive testing expertise to produce efficient, quality database that meets customer requirements. Provide support in creation of Test Plan and handling of validation projects. May act as Validation Team Lead. May undertake selected team leadership activities under supervision of Manager.
  • Independently conduct testing activities to validate Edit Checks, other components, SAS listings, Transfer program and custom reports in platforms like Inform, RAVE, OCRDC, Oracle Clinical. Should have high expertise in Testing activities and excellent knowledge of Database.
  • Advanced understanding of database structures.
  • Perform eCRF and Time & Events QC as per QC checklist.
  • Provide support to Validation Team Leads as required and contribute towards creation of test cases, documentation and communication with internal customers.
  • Support Validation Team Lead in overall management of validation projects. May take complete responsibility for delivery of a validation project.
  • Understand all the documentation requirements with regards to validation very well and update all relevant documents in a timely manner. May monitor documentation compliance for junior team members.
  • Ensure validation processes and best practices are being followed strictly by self and team. May assist with creation/review of now processes/best practices.
  • Communicate status of the projects to the Validation team Lead/Manager/ Data Team Lead/Programmer.
  • Support Validation Team Lead/Manager with daily tasks allocation for validation projects.
  • Escalate problems to the attention of the Validation team Lead or Manager.
  • Conduct Quality Reviews of Testing projects on an ongoing basis as applicable.
  • Conduct Knowledge Sharing and Lessons Learnt sessions regularly.
  • Review and update relevant documents accurately and completely on time. May document all testing documentation in eDMSF.
  • May serve as Subject Matter Expert (SME).
  • Mentor Associate Validation Analysts/Validation Analysts in all validation activities.
  • May provide metrics support to Validation Team Lead or Manager.
  • Identify areas for process improvements continuously. Actively take part and contribute towards process improvement initiatives s assigned besides providing suggestions/ideas for continuous improvement of the process.
  • Understand and comply with core Operating Procedures and Work Instructions (including Best Practice and Guidance documents).
  • Meet project objectives as assigned by Validation Team Lead or Manager.
  • Develop and maintain good communication and working relationships with validation teams across sites.
  • All responsibilities are essential job functions unless noted as nonessential (N).
• 2- 4 years of relevant clinical DB Testing experience in CDMS Platforms and total exp being 4+ yrs
  

Professional Attributes

• Excellent organizational, communication, leadership and computer skills.
• Ability to exercise excellent attention to detail.
• Ability to act independently and with initiative required to resolving problems.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.
• Excellent organizational, communication, leadership and computer skills.
• Ability to exercise excellent attention to detail.
• Ability to act independently and with initiative required to resolving problems.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.

Educational Qualification:

• Bachelor's Degree Clinical, biological or mathematical sciences, or related field Req • Equivalent combination of education, training and experience in lieu of degree.