Lead Data Manager
6 days left
- Experience Level
As a Lead Data Manager, you will be dedicated to one of our global pharmaceutical clients; a prestigious organization, specialising in a niche rare disease, complemented by a pipeline in other therapeutic areas, including oncology. A company that is driving the next generation of patient treatment, where individuals are empowered to work with autonomy and ownership.
As a Lead Data Manager (EDC Database) working on the Clinical Data Management team, you will lead EDC study builds, collaborating with the DM team and vendors.
GENERAL POSITION SUMMARY:
- Leads and manages the EDC study build life cycle for assigned studies, working with functional service provider (FSP) who programs databases
- Ensures consistent use of standards and templates
- Collaborates closely with study data manager for task coordination and information sharing
- Develops specifications for eCRFs, edit checks, system configuration, and IXRS transfers
- Plans, oversees, and participates in User Acceptance Testing. Creates UAT Plan, test scripts, and Summary Report
- Maintains day-to-day contact with database programming staff to handle questions, troubleshoot, help resolve issues and mitigate risks
- Partners with the data manager, medical coder, IXRS analyst, database programmers, and EDC access group to plan for success of study deliverables
- Manages time-sensitive tasks around EDC go-live (coordinating the start of IXRS transfers, EDC access, availability of reports and database extracts)
- Manages database amendments
- Provides expert technical direction; assesses complex technical or procedural issues, chooses among alternatives and facilitates resolutions
- Provides oversight to ensure deliverables adhere to Vertex and industry best practices, and to ensure high quality output is delivered in line with agreed timeline.
- Keep EDC build timelines up to date
- Performs other duties as assigned
- Displays sound project management skills and ability to prioritize workload
- Demonstrates well-developed instincts and problem-solving skills in all areas of data management
- In-depth knowledge of data management systems and processes, analysis and reporting principles
- Excellent teamwork, organizational, interpersonal, conflict resolution, and problem-solving skills
- Comfortable with ambiguity
- Excellent verbal and written communication skills
- Works effectively with global teams in a diverse environment
PREFERRED EDUCATION, EXPERIENCE AND SKILLS:
Prefer B.S. (or equivalent degree) in a scientific or allied health field and 4-6 years of relevant work experience in the Biotech or Pharmaceutical Industry, or equivalent comparable background; Laboratory or sample management experience is a plus
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.
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