Clinical Data Manager
About The Position
Everest Clinical Research is expanding its global biometrics team in Poland and establishing a dedicated biometrics group as part of a Statistical and Data Management Center of Excellence. The company plans to build a team of 20 professionals over the next six months. This role is home-based near Warsaw, Poland, under Everest’s Work from Home policy. The Clinical Data Manager plans, manages, controls, and performs data processing and management for assigned clinical research projects, ensuring timely and accurate work that complies with sponsor requirements. The role leads data management projects, coordinates timelines and activities, oversees clinical data quality and database processes, and collaborates with study teams, data entry personnel, quality assurance staff, and the corporate archivist. Everest describes its work as grounded in high-quality deliverables, customer service, and flexibility.
Requirements
- Bachelor’s degree in health and/or pharmaceutical sciences, physical or biological sciences, or chemistry, with at least 2 years of experience in clinical trial data capture and management; or a Master’s or Ph.D. in these fields with at least 1 year of relevant experience.
- In-depth understanding of clinical trial data management concepts, processes, procedures, and issues that affect clinical data management.
- Understanding of pharmaceutical clinical trial regulations, industry guidance, conventions, and standards.
- Strong leadership in clinical data management activities and a desire to excel in leading data management projects.
Responsibilities
- Plan, manage, control, and perform data processing and management activities for assigned projects in accordance with sponsor requirements.
- Lead assigned data processing and management projects using project management and data management techniques.
- Manage project timelines and coordinate activities.
- Specify database validation checks for assigned studies and help develop and maintain standard checks for common and therapeutic- or drug-area-specific modules.
- Define and monitor clinical trial dataflow and quality control processes in accordance with corporate SOPs, Good Working Practices, and unit guidelines.
- Train clinical trial site monitors on dataflow and QC processes.
- Design and review patient Case Report Forms (CRFs) and database schemas.
- Test data capture and entry screens and validate electronically captured data.
- Write queries for missing data and data that fail predefined range or logical checks.
- Help build a standard query library for common and therapeutic- or drug-area-specific database modules.
- Perform QC procedures on assigned databases during trials and database closure checks at study end.
- Train and supervise data entry personnel and junior data management personnel on study procedures and handling and management of trial data.
- Validate and distribute study progress status reports to internal and external study team members.
- Assist in resolving data coding discrepancies involving medical events, treatment procedures, and medications.
- Maintain and prepare data management documentation for final archival, and assist the corporate archivist with assembling and archiving clinical trial data and study documentation.
- Cooperate with and assist data management QA personnel in QA procedures on trial CRFs, database schemas, and databases for assigned studies.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
