Sr Data Ops Technical Specialist

Overview

Senior Data Operations Technical Specialist role supporting Data Management activities, processes and systems for clinical studies, including leading PDM activities and mentoring Data Management staff.

What you'll do

• Support DM to ensure processes in relation to systems/databases are consistent and that best practices are maintained globally.
• Consult with internal functional teams and sponsors as a subject matter expert.
• Assist with developing, monitoring and enforcing productivity, quality standards and efficiencies, and input into project and timeline metrics.
• Maintain awareness of potential out of scope work for assigned projects and support Lead Clinical Data Manager (LCDM) as appropriate.
• Participate in and present at internal, sponsor, third-party, and investigator meetings.
• Participate in and support internal and external audits and inspections.
• Support the development of User Test Plans for data entry screens, electronic edit checks, data listings, import/export programs and medical coding.
• Support the release of tested clinical data databases and updates to the production environment.
• Support the development of CRF and eCRF completion guidelines.
• Support the development and review of specifications for listings and summaries (other than for statistical reporting requirements) from CRF databases and external sources.
• Participate in the development of departmental technologies, SOPs, processes and procedures.
• Support and participate in the testing and integration of new technologies within Data Operations.
• Maintain documentation on an ongoing basis and ensure that all TMF filing is correct and up to date.
• Train and mentor Data Management staff.
• Maintain proficiency in Data Management systems and processes through regular training.
• May represent Data Operations in company-wide initiatives.
• Perform other work-related duties as assigned.

What you'll need

• 7+ years of Data Management experience.
• At least 2 years of hands-on experience leading PDM activities/projects.

Details

• Location: Hyderabad, India.
• Work mode: Hybrid.
• Minimal travel may be required (up to 25%).