Senior Data Operations Technical Specialist
Why Syneos Health
- We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
- We are committed to our Total Self culture where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
- We are continuously building the company we all want to work for and our customers want to work with. WhyBecause 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 Responsibilities
Job Summary
Supports Data Management in meeting technical deliverables for studies and creating and providing technical solutions to enable efficient processes. Uses expertise in primary development tools and supporting integration of new technologies within Data Operations.
Core Responsibilities -
Supports development of specifications for technical data management processes and systems
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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
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Acts as Subject Matter Experts (SME) for designated systems/databases used by Data Management (DM)
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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
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Assists with developing, monitoring and enforcing productivity, quality standards and efficiencies, input into the development of project and timeline metrics
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Maintains awareness of potential out of scope work for assigned projects and supports Lead Clinical Data Manager (LCDM) as appropriate
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Participates in and presents at internal, sponsor, third-party, and investigator meetings
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Participates in and supports internal and external audits and inspections
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Supports the development of User Test Plans for data entry screens, electronic edit checks, data listings, import/export programs and medical coding
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Supports the release of tested clinical data databases and updates to the production environment
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Develops and/or delivers:
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Supports the development of CRF and eCRF completion guidelines
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Supports the development and review of specifications for listings and summaries (other than for statistical reporting requirements) from CRF databases and external sources
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Participates in the development of departmental technologies, SOPs, processes and procedures
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Supports and participates in the testing and integration of new technologies within Data Operations
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Maintains documentation on an ongoing basis and ensures that all TMF filing is correct and up to date
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Train and mentor Data Management staff
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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
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May represent Data Operations in company-wide initiatives
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Performs other work related duties as assigned. Minimal travel may be required (up to 25%)
Additional Qualification:
We are always excited to connect with great talent. This posting is intended for an upcoming opportunity rather than a live role. By expressing your interest, youll be added to our talent pipeline and considered should this role become available.
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Bachelor s degree, Master s degree preferred, or RN. In lieu of Bachelor s degree or RN, equivalent related education and experience.
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Overall 6 years of experience with EDC Build in Setup, (Writing specification, Performing UAT, Writing Listings, understanding of protocol, understanding of Architect)
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EDC: Rave / Veeva.
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Good mentoring skills with the ability to explain technical processes
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Effective communication, presentation, interpersonal skills, both written and spoken
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Good organizational, planning and time management skills
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Ability to multitask to deliver to tight deadlines while providing attention to detail
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Ability to be flexible and adapt to change, working independently and as part of a global multi-disciplinary team
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Possesses a positive attitude and works well with others
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Knowledge of ICH/GCP regulatory requirements for clinical studies
