Senior EDC Lead

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.
• 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.
• 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, 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.
• 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 to functional quality standards.
• Stays abreast of new and/or evolving local regulations, guidelines and policies related to clinical development.

Qualifications

• Bachelor’s degree in business, management information systems, computer science, life sciences or equivalent.
• Masters preferred.
• Must have 5+ 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 process.
• 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.