Validations Technical Manager - (1807798) in Bloemfontein, ZA at IQVIA™

Date Posted: 6/25/2018

Job Snapshot

Job Description

Join us on our exciting journey!

IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward.

PURPOSE

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.

RESPONSIBILITIES

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 new processes/best practices.

Conduct Quality Reviews of Testing projects on an on-going basis as applicable.

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.

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).



Job Requirements

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

  • Good understanding of CDMS databases.
  • Good computer skills – Microsoft Office applications, especially MS Excel.
  • Good understanding of Clinical Research domain, ICH-GCP guidelines
  • Good understanding of the various processes and aspects of Clinical Data Management activities with respect to Validation.
  • Good analytical skills and detail orientated.
  • Ability to understand complex/dynamic logics in test plan and identify gaps (if any).

 MINIMUM REQUIRED EDUCATION AND EXPERIENCE

Bachelor in Science/Computer science/Information Technology or Bachelor in Technology with 4 to 6 years of Testing experience in CDMS Platforms OR equivalent combination of education and experience.

 

PHYSICAL REQUIREMENTS

  • Extensive use of telephone and face-to-face communication requiring accurate perception of speech
  • Extensive use of keyboard requiring repetitive motion of fingers
  • Regular sitting for extended periods of time
  • Extensive need to view computer screen for extended periods of time.
We know that meaningful results require not only the right approach but also the right people. Regardless of your role, we invite you to reimagine healthcare with us. You will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes.

Whatever your career goals, we are here to ensure you get there!

We invite you to join IQVIA™.



Job ID: 1807798

Check Out Similar Jobs

  1. Project Jobs
  2. IT Project Manager Jobs