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Data Manager / Sr Data Manager
Posted: January 23, 2014
Expires: March 23, 2014
Requisition number: 1296BR
Science jobs from Regeneron Pharmaceuticals, Inc.:
Summary: Works collaboratively with vendor Project Managers and Clinical Data Managers to assure that Data Management functions are performed in compliance with regulations and according to study protocol and the Study Data Management Manual (DMM). Works with involved parties to assure that DMM is prepared according to company SOP's and in compliance with Regeneron's data standards. Coordinates, leads and performs clinical data management activities for assigned studies in accordance with Regeneron's SOP's and policies and practices.
Responsibilities: Serves as primary DM contact for assigned studies, including representation on project teams and working with CRO's performing data management tasks for assigned study.
Coordinates, leads and performs clinical data management activities for assigned studies in accordance with Regeneron's SOP's and policies and practices including, not limited to: Monitors data clean-up process performed by CRO's from study start-up through data archiving. Provides data for analysis Coordinates activities including: medical coding; data validation checks and database snapshot Prepares and distributes project status reports to project team and management.
Functions as DM team leader responsible for ensuring databases are validated and ready for transfer and/or analyses in accordance with Regeneron SOP's.
Creates and maintains project documentation, including, but not limited to, Data Management Manual, CRF Completion Guidelines and validation specifications, and work instructions for assigned projects. Designs and modifies CRF. Responsible for the initiation and approval of the building, testing and validation of clinical databases, subsequent changes in clinical databases and data validation activities. Contributes to upkeep Regeneron DM outsourcing strategies and long-term relationships with outsourcing partners with objective of ensuring data quality and efficiencies through data and process standardization. Works with study team and coordinates all data management functions. Manages coordination of CRO data manager and project team to ensure that tasks are performed according to policies and procedures. * Adheres to procedures surrounding retention of data, records, and information for clinical studies
Experience and Required Skills: Requirements: Bachelor degree in Mathematics, Science or a related field, along with 5-8 or more years of clinical data management experience in biotechnology, pharmaceutical or health related industry. Previous oncology and/or ophthalmology experience a plus. Self-directed and comfortable working in teams with the ability to work and operate independently within a tight deadline environment. High degree of creativity, latitude and attention to detail required. Familiarity with all applicable regulations including; CFR, GCP, and ICH Guidelines. Strong analytical and project management skills. Strong written and oral communication skills required. Proficient with appropriate EDC applications and Microsoft Office applications. Software proficiency with CDMS required. Experience with JMP and SAS a plus. The level is commensurate with the candidate's experience and qualifications. This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.
Apply for Regeneron Pharmaceuticals, Inc.
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