Specialist, Clinical Data Management – Hybrid
About the position Primary activities include, but are not limited to: 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. 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 implements them. Work effectively among team to communicate issues and ideas to improve the 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, automations, initiatives, testing of new systems, and ongoing training and mentoring. Education: B.A. or B.S. degree, preferably in mathematics, science, a healthcare-related discipline, or computer science; or relevant Pharma skills and experience. Knowledge and Skills: 4+ years’ experience in a. SQL, PL-SQL, PowerBI Expected to have a strong technical proficiency in a Clinical Data Management/Reporting Systems like Databricks, Python, SAS, etc along with AI related tools. Solid knowledge of MS Windows/Office 365 suit 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. Possesses excellent communication skills and interacts effectively with Study Team along with 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 Responsibilities • 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. • 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 implements them. • Work effectively among team to communicate issues and ideas to improve the 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, automations, initiatives, testing of new systems, and ongoing training and mentoring. Requirements • B.A. or B.S. degree, preferably in mathematics, science, a healthcare-related discipline, or computer science; or relevant Pharma skills and experience. • 4+ years’ experience in a. SQL, PL-SQL, PowerBI • Expected to have a strong technical proficiency in a Clinical Data Management/Reporting Systems like Databricks, Python, SAS, etc along with AI related tools. • Solid knowledge of MS Windows/Office 365 suit 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. • Possesses excellent communication skills and interacts effectively with Study Team along with 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 Benefits • medical • dental • vision healthcare and other insurance benefits (for employee and family) • retirement benefits, including 401(k) • paid holidays • vacation • compassionate and sick days