EDC Systems Designer / Analyst

Description

• Data Science is the best-in-class team within its cross-industry peer group and is responsible for bringing people, process, and technology together to generate business value from clinical trials data.
• Our operational model is exemplified through execution and innovation.
• This role is key to ensuring successful delivery against the program- and study-level accountabilities assigned to Clinical Data Strategy Organization.
• Actively participates in the development of common data standards and ensures systems designs comply with the standards, as well as with associated protocol requirements.
• Ensures that the design team utilizes standards
• Establishes and maintains methodology used by the team to design and develop clinical trial systems, benchmarking against industry standards.
• Ensures that systems are specified to optimize functionality, end user experience, and data flow.
• Ensures that the design team meets these expectations
• Ensures that TA- and program-level consistency is achieved by the design team
• Accountable for the on-time design and delivery of new clinical systems, integration between systems, as well as any required changes to clinical systems (e.g., EDC, IRT, ePRO).
• Utilizes project management tools to track study progress and plan work.
• Anticipates and identifies issues that could affect timelines or quality and develops options and solutions
• Interacts with and influences CDO and cross-functional team members to achieve program and study objectives.
• Ensures that assigned work product is synchronized with upstream and downstream dependencies
• Ensures adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, Standard Operating Procedures (SOPs), and functional quality standards.
• Stays abreast of new and/or evolving local regulations, guidelines and policies related to clinical development
• Responsible for coaching and mentoring members of the team, as well as contributing to their skill development
• Leads CDO and cross-functional innovation and process improvement initiatives
• Author and maintain EDC specifications
• Ensure compliance with CDASH/SDTM data standards
  
  

Qualifications

• Bachelor's degree in business, management information systems, computer science, life sciences or equivalent required (Masters preferred)
• Must have 6-7 years of hands-on technical Study build in EDC.
• Experience with technical study build in Medidata RAVE is required.
• Veeva EDC technical study build experience is a plus.
• In-depth knowledge of clinical trial processes.
• In-depth knowledge of CDASH (Required) and SDTM.
• Demonstrated performance as a key contributor to initiatives and advancement of the organization.
• Demonstrated ability to influence others without direct authority.
• Demonstrated ability to successfully coach / mentor in a matrixed environment.
• Demonstrated effective communication skills and analytical skills.
• Experience reading and interpreting clinical study protocols to accurately translate protocol requirements into EDC builds
• Ability to design EDC studies from scratch, including form layouts, edit checks, derivations, branching logic, and query workflows
• Ability to coordinate and collaborate with clinical operations, data management, biostatistics, programming, and statistical programming teams to ensure EDC builds meet study requirements
  
  

Benefits

Healthcare Insurance: Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. Premiums are subsidized by Synectics.

Dental Insurance: Synectics offers eligible employees and their dependents a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.

Vision Insurance: Synectics offers eligible employees vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.

401(k) Plan: The Synectics Inc. Investment Savings Retirement Plan. Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first of the month following at least 1 calendar year after employment begins.

Synectics is an equal opportunity employer.