Summary: Provides support to the Lead Data Manager and other study team members. Performs or leads all tasks related to database build and testing. Leads the development of data management-related study documentation and study meeting agendas and minutes. Performs all data cleaning activities (query review and resolution, data listing review). Liaises directly with internal and sponsor study teams. May also be responsible for the development and review of company standard operating procedures and development of study department performance metrics.
- Ownership for timely, complete, and accurate project deliverables within the data management scope of services.
- Development of the eCRF database and related edit checks from the study protocol.
- Development of the eCRF Completion Guidelines.
- Create and maintain data management study documentation (Data Management Plan, eCRF completing guidelines, edit check specifications, data management report specifications, project specific training, Electronic Data Capture testing).
- Participate in and oversee user acceptance testing.
- Oversee issuance of queries and review query responses.
- Ensure all database modifications are communicated to team members.
- Interact with sponsor, sites, and study team members on data cleaning and review activities.
- Participate in and lead client team meetings with respect to data management activities as needed.
- Provide training to study team on use of electronic study database via web conference or in-person.
- Manage the data management portion of the clinical study budget.
- This position requires five years of hands-on clinical data management experience, preferably in a CRO setting, and a minimum of one year in leadership and mentoring within clinical data management.
- Knowledge of Good Clinical Practices (GCP) and Good Clinical Data Management Practices (GCDMP).
- Experience with one or more commercial EDC platforms (Medrio, MedNet, Merge, RAVE).
- Competent computer skills including MS Office Suite.
Skills & Attributes:
- Customer service oriented.
- Demonstrated good communication skills (written and verbal).
- Attention to detail.
- Manner of interactions demonstrates an understanding of the value of developing positive relationships.
- Able to resolve routine problems and elevate issues appropriately.
- Able to work in a fast-paced environment that requires effective multi-tasking and ability to easily adapt to changing priorities.
- Possesses active listening skills and proactively seeks clarification and additional information as needed.
- Works well as part of a dynamic project team, actively supporting other team members and identifying opportunities to contribute.
- Ability to learn new things and teach others.