Summary: Provides operational data management project leadership and directly manages Clinical Data Leads (CDL’s) and Clinical Data Coordinators (CDC’s). Must be an expert in the technical responsibilities of the position. Manages the data management deliverables, ensuring that the quality of data is consistent with the sponsor and departmental expectations and aligns with the study protocol.
- Provide leadership to Clinical Data Leads and Clinical Data coordinators in the planning, implementation, and closeout of data management activities for clinical research projects.
- Ensure that project activities are produced according to the study scope, budget, and timelines.
- Oversight of external data management resources and vendors if any data management study activities are being performed by another service provider.
- Oversight and review of all database development activities including, but not limited to, eCRF development, Data Validation Specifications development, eCRF Completion Guidelines development, User Acceptance Testing, and Data Management Plan development.
- Work actively with the clinical and data management study teams to review study data and ensure data quality.
- Identify and escalate any risks to database integrity, study timelines, and resourcing to the appropriate individuals.
- Responsible for communicating with internal study teams, sponsor study teams, and study stakeholders on data management progress, timelines, issues, and risks.
- Participate in and lead client team meetings with respect to data management activities as needed.
- Ensure appropriate training to the study team on the use of electronic data capture technology.
- This position requires a B.S./B.A. or advanced degree and at least 6 years of clinical data management experience, preferably in a CRO setting.
- Requires at least two years in a leadership position.
- Experience with two or more commercial Electronic Data Capture platforms is required.
- Must have a good understanding of clinical research operations including GCP and regulatory requirements and operational procedures.
- Experience in ophthalmology preferred.
- Experience in a CRO setting is strongly preferred.
Skills & Attributes:
- Must be highly customer service oriented and have creative initiative with a positive attitude.
- Understands and shares the organizational values of developing and maintaining good relationships internally and externally. Quality of interactions reflects emphasis on relationships.
- Able to work in a fast-paced environment and easily adapt to changing priorities.
- Must have excellent management and communication skills (written and verbal), strong problem-solving skills, and be detail oriented.
- Advanced skills in computer operation, spreadsheet creation/maintenance, word processing and electronic data captures systems are essential.