Sr. Clinical Data Manager (Clinical) - REF8985V
- Western Ave, Western Springs, IL 60558, USA
- Employees can work remotely
ProPharma Group is an industry leading, single source provider for regulatory compliance, pharmacovigilance, and medical information services across the full development lifecycle for pharmaceutical, biotechnology, and medical device companies. Operating around the world with offices in Australia, Canada, Germany, Japan, the Netherlands, Sweden, United Kingdom, and the United States, ProPharma Group’s fully integrated service offerings will provide clients with a comprehensive suite of global support services that are required to be competitive in today’s dynamic markets. We build successful long-term relationships with clients by providing leading industry knowledge, experience, and proven processes.
The Sr. Clinical Data Manager reports to Vice President Data Management and Database Programming and provides data management support to ProPharma Group clients.
Essential Functions Include:
- Act as the Lead Data Manager for one or multiple studies.
- Complete Data Management tasks for assigned studies under minimal supervision according to the study contract and applicable SOPs.
- Develop and maintain study-specific documentation, including Data Management Plans, eCRF specifications, CRF Completion Guidelines, Data Validation Guidelines, add Data Transfer Specifications, Coding Guidelines, Post Production Database Change Control Documentation, Database Audit and Lock Procedures.
- Work with database programmers to design (e)CRFs and edit checks in EDC system.
- Create test data for User Acceptance Testing (UAT).
- Perform and document database UAT.
- Receive, integrate, and reconcile electronic data.
- Perform data review via listings and EDC system, issue and resolve queries.
- Manage queries to ensure data completeness and integrity.
- Assist with data listing design for data review.
- Perform SAE reconciliation.
- Perform pre-lock and data lock tasks.
- Participate in client and team meetings as required.
- Design, generate, and review status metric reports as needed.
- Perform archiving of study databases and related documents
- Provide input to timelines to ensure timely completion of assigned tasks.
- Provide regular status updates and keep the team and management informed of any changes.
- Organize and file study documentation.
- Work with management and senior DM personnel to implement technical solutions and resolve issues.
Qualified candidates must have:
- Minimum BS in a scientific or health related field or the equivalent in years of experience.
- Minimum 5 years in Clinical Data Management.
- Minimum 1 year acting as a Lead Data Manager on one or multiple projects (study start up through database lock).
- Expertise with EDC systems, such as Medidata Rave, InForm, IBM Clinical, Veeva EDC or Medrio.
- Excellent communication and time management skills.
All candidates must be legally eligible to work in the United States.
We are an equal opportunity employer. M/F/D/V
***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***