Data Operation Technical Specialist
- Syneos Health
- 4 - 9 years
- Pune
- 2 months ago
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Job Description
Role & responsibilities:
Supports development of specifications for technical data management processes and systems
Contribute to the Request For Proposal (RFP) and Request for Information (RFI) process
Prepares input for proposal bid defense meetings where appropriate
Acts as Subject Matter Experts (SME) for designated systems/databases used by Data Management (DM)
Supports DM to ensure processes in relation to systems/databases are consistent and that best practices are maintained globally. Can consult with internal functional teams and sponsors as a SME
Assists with developing, monitoring and enforcing productivity, quality standards and efficiencies, input into the development of project and timeline metrics
Maintains awareness of potential out of scope work for assigned projects and supports Lead Clinical Data Manager (LCDM) as appropriate
Participates in and supports internal and external audits and inspections
Supports the development of User Test Plans for data entry screens, electronic edit checks, data listings, import/export programs and medical coding
Supports the release of tested clinical data databases and updates to the production environment
Develops and/or delivers:
o Applicable data management departmental training related to technical processes and systems
o Other project specific training
Supports the development of CRF and eCRF completion guidelines
Supports the development and review of specifications for listings and summaries (other than for statistical reporting requirements) from CRF databases and external sources
Participates in the development of departmental technologies, SOPs, processes and procedures
Supports and participates in the testing and integration of new technologies within Data Operations
Maintains documentation on an ongoing basis and ensures that all TMF filing is correct and up to date
Train and mentor Data Management staff
Maintains proficiency in Data Management systems and processes through regular training.
Job Classification
Industry: Pharmaceutical & Life SciencesFunctional Area / Department: Research & Development, Role Category: Pharmaceutical & BiotechnologyRole: Pharmaceutical & Biotechnology - OtherEmployement Type: Full timeContact Details:
Company: Syneos HealthLocation(s): Pune
Keyskills: Clinical Data Operation Clinical Data operation Management Clinical Data Management Clinical Data Clinical Data Validation
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