Clinical EDC Systems Expert

Job Title: Clinical EDC Systems ExpertAbout the Role:We are seeking a highly skilled Clinical EDC Systems Expert to join our team. In this role, you will be responsible for designing, developing, and implementing clinical trial setups using Electronic Data Capture (EDC) systems.Key Responsibilities:Create accurate and efficient eCRF specifications, design, and develop the clinical trial setup process.Design and implement edit check specifications and set up edit checks at the trial level to maintain data quality.Develop and execute UAT scripts to test the clinical study setup, ensuring correctness.Set up different instances of study URLs (e.g., UAT, production, testing) for seamless navigation.Configure user accounts for study teams, promoting collaborative work and efficient information exchange.Manage blinded and unblinded study configurations with precision, ensuring compliance and integrity.Serve as the SME for all EDC database-related activities, providing expert guidance and support.Integrate and configure other modules within the EDC ecosystem, such as coding, integration of IRT, safety systems, and local labs, to optimize overall performance.Demonstrate a thorough understanding of when custom functions are required within EDC systems, ensuring seamless execution.Effectively troubleshoot database setup issues based on study needs, resolving problems promptly.Prepare, test, and implement post-production changes according to study requirements, maintaining adaptability and flexibility.Collaborate with appropriate team members to establish technology standards and governance models, fostering innovation and best practices.Oversee the system delivery life cycle in partnership with Clinical Operations, Clinical Supplies, IT, and Quality organizations, ensuring success and satisfaction.Promote the adoption of new capabilities and business processes, driving organizational growth and improvement.Serve as the primary point of contact for Clinical Technology vendors to ensure established milestones are met with the highest degree of quality.Work closely with leaders to resolve issues affecting the delivery of clinical trials, demonstrating effective problem-solving skills.Partner with data engineers and data management programmers on study-level integrations and deliveries, enhancing collaboration and results.Lead technology vendor oversight activities, prioritizing quality and effectiveness.Collaborate with appropriate team members, technology vendors, and CRO partners to identify and mitigate risks, ensuring successful outcomes.Confirm archival and inspection readiness of all Clinical Technology Trial Master File (TMF) documents, maintaining compliance and transparency.Participate in preparing function for submission readiness and represent the Clinical Information Operations (CIO) group in formal inspections or audits, upholding professional standards.Track study deliverables and evaluate study metrics to mitigate risk for major data management deliverables, promoting accountability and efficiency.Adeptly adapt to new ways of working using technology to accelerate clinical trial setup, embracing innovation and progress.About Us:We are a leading organization dedicated to delivering innovative solutions in clinical trials. Our team is passionate about making a difference and committed to excellence in all we do.What We Offer:Opportunity to work with cutting-edge technologies and contribute to groundbreaking research.Collaborative and dynamic work environment that fosters growth and development.Competitive salary and benefits package, including health insurance, retirement plan, and paid time off.Ongoing training and professional development opportunities to enhance your skills and knowledge.Chance to make a meaningful impact on patients' lives and contribute to improving healthcare outcomes.