Overview: Responsible for successfully providing data management deliverables that meet internal and external client needs.
- Serves as the primary contact for internal and external team members regarding data management activities.
- Authors documents such as interim lock plans, database closure plans, and database unlocking plans.
- Tracks milestones, tasks, and the overall budget for assigned projects.
- Participates in sponsor and/or third-party audits.
- Forecasts units, hours, and resourcing for data management tasks.
- Develops plans and oversees timeliness for activities between the last patient visit and the database lock.
- Contributes to bid and proposal development and participates in bid defense meetings.
- Takes a lead role in PRA and data management initiatives.
- Responsible for owning and achieving interim and final contractual deliverables for assigned projects.
- Ensures quality-control steps are implemented so that quality deliverables are provided.
- Mentors and trains other data management team members.
- Writes articles for industry publication and gives presentations at industry conferences.
- May act as portfolio-level data manager as necessary across projects with lead data managers assigned.
- Advanced knowledge of computerized information systems and standard application software (Windows, MS Office).
- Understands clinical data management systems or electronic data capture software.
- Advanced understanding of clinical data management and each function as it relates to data management.
- Expertise in all aspects of the life cycle of a data management study.
- Acts as a subject matter expert (SME) for various technologies or processes.
- Performs duties at a high standard with limited supervision.
- A Bachelor’s degree in Allied Health, Bio-Medical, Clinical Informatics, or a related field is required.
- At least 7 years of data management experience is required.
- At least 2 years of experience working for a CRO, within the last 5 years, is required.
- Leadership experience, specifically as the primary point of contact for a Clinical Data Management project team.
- Lead experience managing at least 3 studies simultaneously.
- Experience with all steps within the Data Management lifecycle and most major Data Management study tasks, with proficiency in at least one Clinical Data Management system required. Familiarity with Rave is desired.
- Budget experience is required.
- Project management experience is required. Must have experience managing timelines.
- Vendor management or third-party management experience is required.
- Proven history of successful interaction with internal and external clients and an understanding of related functions.
- Bid defense experience, local lab experience, SDTM and Data Programming experience desired. But, not required.
- Unless otherwise noted, must be able to work from PRA office at least 3 days/week.
- To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status.