Job Description - Data Ops Technical Specialist (21004256)
Data Ops Technical Specialist-(21004256)
Data Operations Technical Specialist
Come 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.
• 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.
• May represent Data Operations in company-wide initiatives
• Performs other work related duties as assigned. Minimal travel may be required (up to 25%)
What we’re looking for
• 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
Get to know Syneos Health
We are the only full-service biopharmaceutical solutions company in the world. That means we bring together the best clinical and commercial minds to create a better, smarter, faster way to get medicines into the hands of patients who need it most. Learn more about Syneos Health.
This Job Excludes CO Applicants
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
:North America - USA-N-Carolina-Home-Based
:North America - US Home-Based, North America - CAN-Home-Based
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