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 SOPs and in compliance with company's data standards. Coordinates, leads and performs clinical data management activities for assigned studies in accordance with company's SOPs and policies and practices.
JOB RESPONSIBILITIES:
Contributes to upkeep 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.
JOB REQUIREMENTS:
Education:
• Bachelor’s degree in Mathematics, Science or a related field, along with 3 or more years of clinical data management experience in biotechnology, pharmaceutical or health related industry.
Experience:
• 3 – 5 Years
• Previous oncology and/or ophthalmology experience a plus
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