The position is responsible for hiring, managing, developing and being accountable for the Clinical Data Managers in the assigned team and the department; and for meeting assigned operational targets including but not limited to quality, performance, utilization, retention and SOP training.
- Ensure that all project-related data management tasks are completed in accordance with Biorasi standard practices from commencement to closure of a project.
- Identify and quantify resource requirements for ongoing and future projects.
- Manage billable and non-billable time for the assigned group.
- Interview, hire, onboard and train new staff as appropriate.
- Identify data management project issues and alert Senior Department Management with a view to remedial action.
- Interact with other departments to ensure a high level of client satisfaction through successful execution of projects.
- May assist in the creation and documentation of new or revised departmental procedures.
- May represent Clinical Data Management at Business Development, sponsor related meetings and professional meetings.
- May write training materials and/or perform training for data management staff.
- May participate in the development of department standard operating procedures and guidelines, conducting training and evaluating staffing need.
- May be required to participate in client, internal or agency audits and inspections
- Perform User Acceptance Testing for development study databases; create User Acceptance Testing scripts for study database validation.
- Create data management reports as requested.
- Assist with the preparation, collection, and archival of study related clinical documents.
- Clinical team training on EDC system, study-specific eCRFs, and RTSM applications.
- Participate in vendor management as assigned.
- Supervise, coach, and mentor staff
- Oversee development of direct reports by setting goals, conducting performance reviews, evaluating and monitoring training needs, creating development plans, mentoring, and coaching
- Set priorities and schedule activities of departmental resources, implement company objectives, and create alternative solutions to address business and operational challenges
- Bachelor degree or equivalent in a scientific related discipline.
- Minimum 6yrs of experience in Clinical data Management.
- Experience with Access, SQL, Crystal Reports, JReview, Business Objects XI, or any other reporting tools/coding languages a plus.
- Advanced Excel knowledge preferred.
- Excellent organizational skills; strong verbal and written communications skills.
Biorasi is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. Biorasi is also committed to compliance with all fair employment practices regarding citizenship and immigration status.