IRT - Systems Designer

Job Description

Position Details:

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Position Details:

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Job Title: Systems Designer / Analyst II

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Location: Remote Role

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Duration: 12+ Months (Possible extensions)

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Job Description

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The 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 Data and Statistical Sciences.

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Responsibilities

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• 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
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• 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 on functionality, end user experience, and data flow. Ensures that the design team meets these expectations
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• Ensures that TA- and program-level consistency is achieved by the design team
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• Accountable for the on-time design and delivery of new clinical systems, integrations between systems, as well 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
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• Interacts with and influences DSS and cross-functional team members to achieve program and study objectives. Ensures that assigned work product is synchronized with upstream and downstream dependencies
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• Ensures adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, Client Standard Operating Procedures (SOPs), and to functional quality standards. Stays abreast of new and/or evolving local regulations, guidelines and policies related to clinical development
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• Responsible for coaching and mentoring members of the team, as well as contributes to their skill development
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• Leads DSS and cross-functional innovation and process improvement initiatives
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Qualifications

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• Bachelor’s degree in business, management information systems, computer science, life sciences or equivalent. Masters preferred.
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• Must have 5+ years of clinical technology experience (e.g. EDC, IRT, ePRO) or 7+ years of experience in a similar technical role or in a clinical development role. Experience with common industry design and development tools required.
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• In-depth knowledge of clinical trial process.
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• In-depth knowledge of CDASH and SDTM.
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• Demonstrated performance as a key contributor to initiatives and advancement of the organization.
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• Demonstrated ability to influence others without direct authority.
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• Demonstrated ability to successfully coach / mentor in a matrixed environment.
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• Demonstrated effective communication skills and analytical skills.
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Experience Level = 3-5 Years

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EEO:

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“Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans. ”