This top biopharmaceutical company uses cutting-edge technology to develop groundbreaking treatments in oncology, immunology, and infectious diseases. Their dedication to improving patient outcomes consistently sets new standards in medical innovation.
Job Detail
Job Description
Duties:
• Serves as primary DM contact for assigned studies, including representation on project teams and
working with CROs performing data management tasks for assigned study.
• Coordinates, leads and performs clinical data management activities for assigned studies in accordance
with COMPANY’s SOPs and policies and practices including, not limited to:
o Monitors data clean-up process performed by CROs from study start-up through data archiving.
o Provides data for analysis.
o 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 COMPANY SOPs.
• 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.
Requirements:
- Have a passion for championing and implementing clinical data platform.
- Enjoy working in an innovative and multi-functional team.
- Have strong analytical skills with the ability to collect, organize, analyze, and disseminate significant amounts of information with attention to detail and accuracy.
- Possess Excellent communication, and project management skills.
- 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. Previous hematology oncology, oncology or ophthalmology, experience is a plus.
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