Sr Data Operations Technical Specialist

Sr Data Operations Technical Specialist Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.   Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.   Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver – for one another, our customers, and, most importantly, for those in need.   Discover what your 25,000 future colleagues already know:   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 building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life.  • We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress. 

Job Responsibilities

Job Description

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 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%)

Qualification Requirements 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

4 + years of experience in CDM/Study Startup Designing.

Experience with EDC Build in Setup, (Writing specification - eCRF Specification Design & Data Validation Specification creation, Performing UAT, Writing Listings, understanding of protocol, understanding of Architect)

Preferred EDC: Rave / Veeva.

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 multidisciplinary team

Possesses a positive attitude and works well with others

Knowledge of ICH/GCP regulatory requirements for clinical studies

Get to know Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

http://www.syneoshealth.com

Additional Information

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.