Manager, eSource Architecture & Clinical Systems

Description

Manager, eSource Architecture & Clinical Systems

Join our dynamic team as the Manager of eSource Architecture & Clinical Systems, where you will lead a dedicated team of eSource Architects in designing, implementing, and maintaining electronic source documentation within the Clinical Research Information Organization (CRIO) environment. This pivotal role offers an exciting opportunity to influence clinical research operations by ensuring compliance, enhancing efficiency, and supporting innovative data management solutions.

Key Responsibilities:

- Lead and oversee a team of eSource Architects responsible for the design, development, and support of electronic source documentation systems.

- Develop and implement eSource strategies aligned with organizational goals, regulatory requirements, and sponsor expectations.

- Ensure all systems and processes comply with federal regulations, Good Clinical Practice (GCP) standards, and organizational policies.

- Collaborate with cross-functional teams to optimize study startup timelines, improve site adoption, and enhance data quality.

- Provide quality oversight and continuous process improvement to ensure operational excellence.

- Support clinical research operations by developing scalable processes, training, and best practices.

- Monitor team performance, provide mentorship, and foster a culture of innovation and accountability.

- Maintain up-to-date knowledge of regulatory changes, industry trends, and emerging technologies related to electronic source documentation.

Skills and Qualifications:

- Bachelor's degree in Life Sciences, Healthcare, Information Technology, or a related field; advanced degree preferred.

- Proven experience in clinical systems, eSource architecture, or related roles within a clinical research environment.

- Strong understanding of federal regulations, GCP guidelines, and sponsor requirements related to electronic source documentation.

- Demonstrated leadership skills with experience managing technical teams.

- Excellent project management, strategic planning, and problem-solving abilities.

- Effective communication skills, capable of collaborating across diverse teams and stakeholders.

- Knowledge of clinical trial processes, data management, and regulatory compliance.

- Ability to adapt to evolving technologies and industry standards.

At our organization, we foster a collaborative and innovative culture that values continuous learning and professional growth. We are committed to supporting our team members with comprehensive benefits and opportunities to advance your career in the rapidly evolving field of clinical research technology.