Clinical Data Specialist

1 day ago

Tarrytown, New York, United States System One Full time
Clinical Data Manager Job Description

As a Clinical Data Manager at System One, you will play a crucial role in ensuring the accuracy and integrity of clinical data. Your primary responsibility will be to oversee the data management functions for assigned studies, ensuring compliance with regulations and study protocols. You will work closely with vendor Project Managers and Clinical Data Managers to coordinate data management activities, including data clean-up, data validation, and database snapshot. Additionally, you will be responsible for preparing and distributing project status reports to the project team and management. If you have a passion for championing and implementing clinical data platforms, enjoy working in an innovative and multi-functional team, and possess excellent communication and project management skills, this role may be for you.

Key Responsibilities:

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 client'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 client 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:

Bachelor's degree in Mathematics, Science or a related field, along with 5+ or more years of clinical data management experience in biotechnology, pharmaceutical or health related industry.

Strong analytical skills with the ability to collect, organize, analyze, and disseminate significant amounts of information with attention to detail and accuracy.

Excellent communication, and project management skills.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

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