Clinical Data Manager

Principal Duties and Responsibilities:

• Review data and generate queries according to the data validation specification (DVS)
• Maintain documentation relating to clinical data management including maintaining the data management portion of the Trial Master File
• Write and maintain DVS
• Interface with and train site personnel (globally), monitors (globally) and clinical operations staff to provide support related to data management, including but not limited to the following: EDC issue resolution, acquisition of outstanding data, assisting in visit reconciliation for site payment, and site closure
• Develop trainings for online delivery
• Assist in streamlining clinical data management procedures to create effective practices
• Set up studies in EDC system
• Write edit checks in in EDC software
• Write data listings and simple reports in SQL or R or other languages (on the job training provided), participate in peer code review, validate code, and maintain code repositories
• Contribute to development of reports and plans (ie: clinical study reports/statistical analysis plans)
• Coordinate with pharmacovigilance to review and generate queries related to serious adverse events
• Correspond with and oversee data management vendors
• Coordinate medical coding
• Manage data from external vendors in compliance with 21 CFR Part 11
• Perform tasks according to company standard operating procedures (SOPs)

Qualifications:

Education

• Bachelor’s degree or equivalent experience

Experience/Skills

• Minimum of three years of direct clinical data management experience in the biotechnology or pharmaceutical industry.
• Working knowledge of Good Clinical Practices and ICH guidelines related to CDM
• Exceptional organizational skills, highly adaptive in the face of changing priorities and practices
• Effective written communication skills

Position Requirements:

• May require limited travel for training purposes

NOTE: This description is not intended to be all inclusive or a limitation of the duties of the position. It is intended to describe the general nature of the job which may include other duties as assumed or assigned.