- Education: Minimum of a BS in life sciences or computer science degree
- Minimum of 7 years of Data Management experience in the Biotech/Pharma/CRO industry
- Demonstrated current understanding of GCP and regulatory requirements as they relate to data management systems and activities
- Demonstrated current understanding of Good Clinical Data Management Practices (GCDMP)
- Experience of clinical databases, different clinical data management systems and electronic data capture (EDC)
- Demonstrate understanding and experience in query management process and reconciliation activities
- Strong communication and interpersonal skills
- Ability to work independently under direction and close supervision
- Excellent written and verbal communication skills
- Effective problem and conflict solving skills
- Ability to work in a team environment
- High attention to detail and accuracy
- Strong knowledge of Oncology and Autoimmune disease
- Certified Clinical Data Manager (CCDM) via the Society of Clinical Data Management
- Demonstrated knowledge of clinical and Pharmaceutical drug development process
- State of the art understanding of database structures, data standards (CDISC) and practices as they apply to CRF design, database development, data handling and reporting
- Demonstrated understanding of clinical data system design / development / validation and system interoperability.
- Excellent understanding and demonstration of the
- Immunomedics’ values and behaviors
- Excellent organizational and analytical skills
- Demonstrated ability to work effectively with external partners
- Ability to interact effectively with all levels of management
Physical Requirements and Working Conditions
- Environment: Standard office setting; exposure to computer screens.
- Physical: Primary functions require sufficient physical ability to work in an office setting and operate standard office equipment including use of a computer keyboard. Sedentary work, which includes exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently to move objects. Involves sitting most of the time but may include walking or standing for brief periods of time.
- Vision: See in the normal visual range with or without correction; vision sufficient to read computer screens and printed documents.
- Hearing: Hear in the normal audio range with or without correction.
Principal Interactions (Ecluding Own Department)
Clinical Operations, Clinical Development, Information Technology; Regulatory Affairs