Specialists, Clinical Data Management

Join our team as a Specialists in Clinical Data Management to support our clinical studies. In this role, as a Clinical Data Management Specialist, you'll assumes the responsibilities for all clinical programming (including reporting and analytics) deliverables including Oracle, Veeva platforms along with the external data captured in support of the clinical studies. Primary activities include, but are not limited to: Coordinates and participates in the following activities: Design, build, maintain, test, and document data review based on written specifications established by Global Clinical Data Management, Clinical Research and Global Safety. Review the technical feasibility of study team proposed programming/reporting and technically implement them. Work effectively among teams to communicate issues and ideas to improve business along with understanding of Protocol. Support the development & reporting for data cleaning, medical review, clinical monitoring, and safety reports for quality and timely availability in support of our customer needs. Perform ongoing support for In-Life Reports. Change Requests and Incident Reports are fully documented, signed off, tracked, and reported to upper management. Participate in extra activities including, but not limited to, study improvement task forces, automation, initiatives, testing of new systems, and ongoing training and mentoring.

Associate degree with a minimum of 3 years’ experience working in clinical data programming, data engineering, or related data-management/clinical operations functions OR Bachelor's Degree with a minimum of 2 years’ experience working in in clinical data programming, data engineering, or related data-management/clinical operations functions OR Advanced Degree (master’s or doctorate) with prior experience in clinical development and / or clinical data programming, data engineering, or related data-management/clinical operations activities preferred. Required Knowledge and Skills: Strong technical proficiency in Clinical Data Management/Reporting Systems like Databricks, Python, SAS, SQL/PL SQL, Power BI, etc along with AI related tools. Solid knowledge of MS Windows/Office software and exposure to web-based applications. Solid knowledge of System Development Lifecycle Management / system validation knowledge. Ability to establish and maintain good working relationships with different functional areas. Strong sense of urgency and customer focus. Excellent communication skills and interacts effectively with Study Team. Strong organizational and problem-solving skills. Desire and ability to learn new processes and technologies. Ability to multi-task, work independently, and good communication skills. Understanding of drug discovery process, FDA regulations, GxP guidelines, ICH. #eligibleforERP #clinicaltrialjobs #GDMS Required Skills: Clinical Data Management, Communication, Computer Programming, Data Analysis, Data Management, Data Quality Assurance, Electronic Data Capture (EDC), PL/SQL (Programming Language), SQL Databases, Team Communication Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal