Key skills
LeadershipCommunication
About this role
Role Overview
- Responsible and manages all aspects of the clinical trial data management process
- Oversees and/or perform database development and testing
- Primary Data Management (DM) contact for assigned projects
- Oversee project data entry process
- May perform quality control of data entry
- Provide input, assesses and manage timelines
- Develop CRF specifications from the clinical study protocol
- Conduct database build UAT
- Responsible for creating, revising, appropriate versioning and maintaining data management documentation
- Train clinical research personnel
- Review and query clinical trial data
- Perform medical coding of medical terms
Requirements
- Bachelors and/or a combination of related experience
- 8+ years’ experience
- Able to handle a variety of clinical research tasks
Benefits
- Excellent organizational and communication skills
- Professional use of the English language; both written and oral
- Experience in utilizing various clinical database management systems
- Broad knowledge of drug, device and/or biologic development and effective data management practices
- Strong representational skills, ability to communicate effectively orally and in writing
- Strong leadership and interpersonal skills.
- Systems knowledge with Medidata Rave and Veeva
- Ability to undertake occasional travel