Clinical Data Validation Specialist/Associate Clinical Data Validation

Project Role: Clin DB Validation specialist

Work Experience: 2-10 Years

Work location: Kochi/Bangalore/Pune/Thane/Kolkata

Work Mode: Hybrid

Must Have Skills: clinical data management, startup process, CDM Validation

Shift Timings: General

Job Overview:

Conduct testing activities in CDMS environment and provide comprehensive testing expertise to the

team to produce efficient, quality database that meets customer requirements.

Job Responsibility:

• Independently conduct testing activities to validate edit checks, system settings, SAS listings, Transfer

Programming and custom reports in platforms including, InForm, RAVE, OCRDC.

• Solid understanding of database structure.
• Ensure validation processes and best practice guidelines are being followed strictly by self and team.
• Solid understanding of documentation requirements and update all relevant documentation in a timely manner.
• Communicate status of project to Validation Team Lead/Manager.
• Escalate problems to the attention of Validation Team Lead/Manager.
• Mentor Associate Validation Analysts in all testing activities.
• Conduct Quality Reviews of testing projects on an ongoing basis as applicable.
• Provide suggestions for continues process improvement and actively participate and contribute

towards process improvement initiatives as assigned.

• 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/Manager.
• Develop and maintain good communications and working relationships with multiple teams across locations.

Technical Skills:

Medical terminology exposure.

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 bachelors in science/computer science/Information Technology or bachelors in

technology Req

• 2+ years of relevant clinical DB Testing experience in CDMS Platforms and total exp being 2+ yrs