Senior Data Operations Technical Specialist

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 and participates in 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 presents at internal, sponsor, third-party, and investigator meetings
• 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:
• Applicable data management departmental training related to technical processes and systems
• 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. May attend/represent the company at professional meetings/conferences. Takes the opportunity to network with colleagues for new and/or repeat business
• May represent Data Operations in company-wide initiatives

Preferred candidate profile

• Overall 6 years of experience with EDC Build in Setup, (Writing specification, Performing UAT, Writing Listings, understanding of protocol, understanding of Architect)