Clinical Data Manager - Oncology

Clinical Data Manager

As a Clinical Data Temp, a typical day may include serving as the primary Data Manager contact for assigned studies, including representation on project teams and working with CROs performing data management tasks for assigned studies.

Job Description

• Coordinates, leads, and performs clinical data management activities for assigned studies in accordance with clients' SOPs and policies and practices, including monitoring the data clean-up process performed by CROs from study start-up through data archiving.
• Provides data for analysis and coordinates activities including medical coding, data validation checks, and database snapshots.
• Prepares and distributes project status reports to the 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, 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 the upkeep of DM outsourcing strategies and long-term relationships with outsourcing partners with the objective of ensuring data quality and efficiencies through data and process standardization.
• Works with the 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.

Requirements

• Bachelor's degree in Mathematics, Science, or a related field.
• 3 or more years of clinical data management experience in biotechnology, pharmaceutical, or health-related industry.
• Previous oncology and/or ophthalmology experience is a plus.

Benefits

• System One offers eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

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.