Systems Designer \\/ Analyst III

Spectraforce Technologies, Inc.; Avon-by-the-Sea (NJ); On-site; USD 120,000 - 150,000; Full time

Job summary

AbbVie is seeking a Senior Clinical Data Systems Specialist to lead standardization and design of clinical trial systems. You will ensure compliance with CDASH/SDTM and drive data quality and integration across EDC platforms.

Responsibilities include establishing common data standards, mentoring team members, coordinating with CDO and cross-functional partners, and delivering timely system designs in alignment with regulatory requirements.

Qualifications

• Bachelor's degree in business, MIS, computer science, life sciences or equivalent. Masters preferred.
• 7+ years of hands-on technical Study build in EDC.
• Experience with Medidata RAVE is required.
• Veeva EDC experience is a plus.
• In-depth knowledge of CDASH and SDTM.
• Strong communication and mentoring skills.
• Ability to influence others without direct authority.

Responsibilities

• Develop and enforce common data standards for clinical trial systems.
• Ensure designs comply with standards, protocols, and regulatory requirements.
• Lead on-time design and delivery of new clinical systems and integrations.
• Mentor team members and drive process improvements.
• Coordinate with CDO and cross-functional teams to achieve objectives.
• Track progress using project management tools and manage timelines.

Skills

Data standards

Project coordination

Communication

Leadership

Education

Bachelor's degree in business, MIS, CS, life sciences or equivalent

Master's degree preferred

Tools

Medidata RAVE

Veeva EDC

Electronic Data Capture (EDC)

CDASH tooling

Job description

Length of contract: 1 Year extended for 2nd year, post PE. Location/Site: Prefer - New Jersey or close to another Abbvie office, or must be willing to relocate if offered FTE position.

Purpose: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.

Responsibilities

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, AbbVie 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.

Qualifications

Bachelor's degree in business, management information systems, computer science, life sciences or equivalent. Masters preferred. Must have 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.

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