Trial Coordinator / Data Manager II - Level 1

Frontier Science is looking for a Data Manager who also acts as a Clinical Trials Coordinator for the International Breast Cancer Study Group, a non-profit clinical trials research organization. This position will work internally with data management teams, trial coordinators, biostatisticians, and programmers, as well as external healthcare sites, medical personnel, and study teams.

Primary Areas of Responsibility:

• Review, validation, and quality control of clinical trial data (patient history, tumor characteristics, treatment, Adverse Events, follow-up, etc.)
• Discrepancy checking, querying, and query resolution
• Create and test edit checks
• Trial database set up and user acceptance testing
• Support of site personnel via email, phone or web-based trainings
• Participate in development and review of policies and procedures
• Development, review and understanding of data management documentation (protocols, manuals, case report forms, etc.)
• Production of quality control reports
• Communicate with study team and sites regarding clinical trial start-up, training, conduct and close-out activities
• Collect and review regulatory documents from sites
• Create, organize and maintain tracking systems and tools to support the conduct of trials from start-up to close-out
• Distribute and triage communications to/from sites, external collaborators, and colleagues

Requirements:

• Bachelor's Degree, preferably in a related field
• Familiarity with medical concepts and terminology
• Documentation experience
• Excellent writing and communication skills and the ability to build effective relationships with site staff and colleagues
• Strong working knowledge of MS Office Suite and excellent overall technical skills
• Excellent organizational and problem-solving skills
• Detail-oriented, resourceful, positive and professional demeanor
• Ability to work with people from diverse backgrounds, work independently, multi-task, adapt to changing priorities, perform job duties with minimal guidance, and meet deadlines

Highly desirable but not required:

• Prior Clinical Trials management experience
• Foreign language skills (especially German and Italian)
• Knowledge of DFExplore database management system