Data Operations Technical Specialist

Job Description

*Data Operations Technical SpecialistCome discover what our 25,000+ employees already know: work here matters everywhere. We re a growing and evolving biopharmaceutical industry leader, which means you ll have endless opportunities to work with experts around the world and build the career you ve dreamed of. As a part of the Syneos Health team, you ll help us deliver results for a rewarding reason we improve patients lives around the world. Because to us, a patient isn t just a number, they re our family, friends, and neighbors.Why Syneos Health #SyneosHealthLife means we re committed to our Total Self culture where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person s unique contributions make a difference. We believe our success is a direct result of the people who are driving it you We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That s why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial. We are continuously building the company we all want to work for and our customers want to work with. Why Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives we re able to create a place where everyone feels like they belong.JOB SUMMARYSupports Data Management in meeting technical deliverables for studies and creating and providing technical solutions to enable efficient processes. Uses expertise in primary development tools within Data Operations.JOB 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:
  • 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 represent Data Operations in company-wide initiatives
• Performs other work related duties as assigned. Minimal travel may be required (up to 25%)

• Bachelor s degree, Master s degree preferred, or RN. In lieu of Bachelor s degree or RN, equivalent related education and experience.
• Good ability to explain technical processes
• Effective communication, presentation, interpersonal skills, both written and spoken
• Good organizational, planning and time management skills
• Ability to multitask to deliver to tight deadlines while providing attention to detail
• Ability to be flexible and adapt to change, working independently and as part of a global multi-disciplinary team
• Possesses a positive attitude and works well with others
• Knowledge of ICH/GCP regulatory requirements for clinical studies

Keyskills :
windowstroubleshootingcustomer relationssubject matter expertsdata entryclinical dataexternal auditdata managementtime managementaudio masteringstatements of work sow