Clinical Data Manager

Everest Clinical Research Corporation; Warszawa; Hybrid; PLN 180,000 - 240,000; Full time

Benefits offered by this job

Work from home

Job summary

Everest Clinical Research is expanding its biometrics group in Poland and invites you to join the global biometrics team as a Clinical Data Manager remotely from a home-based office near Warsaw, Poland in accordance with our Work from Home policy.

You will plan, execute, and oversee data processing, QC, and database design activities across trials, train junior staff, and ensure data integrity and timely delivery.

Qualifications

• Bachelor’s degree with at least 2 years in clinical trial data capture/management, or Master’s/PhD with at least 1 year relevant experience.
• In-depth understanding of clinical trial data management concepts, processes, procedures, and related regulations/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.
• Lead assigned data processing and management projects, coordinating timelines and activities.
• Define and monitor dataflow, QC processes, and SOP-compliant workflows; train site monitors on dataflow and QC.
• Design and review CRFs and database schema; test data capture/entry screens.
• Validate electronically captured data; write queries for missing or out-of-range data; develop a standard query library.
• Perform QC on databases during trials and at study end; train Data Entry personnel and junior staff.
• Distribute study progress reports to internal/external team members; assist in resolving data coding discrepancies.
• Maintain archival-ready data management documentation and assist QA personnel with data-related QA procedures.

Skills

Clinical data management

Project leadership

Data validation

Regulatory knowledge

Team supervision

Education

Bachelor’s degree in health/pharma sciences

Master’s/PhD in related field

Job description

Everest Clinical Research is a global Clinical Research Organization that proudly maintains a regional clinical operations hub in Warsaw. Now, Everest's global biometrics team is embarking on an exciting phase of growth, and we're thrilled to announce the biometrics team's expansion in Poland with the establishment of a dedicated biometrics group. Over the next 6 months, Everest plans to build a dynamic team of 20 talented professionals who are passionate about biometrics. If you're driven by data, eager to make a meaningful impact, and want to be part of a Statistical and Data Management Center of Excellence, we invite you to join our global biometrics team and help shape the future of clinical research.

Everest is known in the industry for its high quality deliverables, superior customer service, and flexibility in meeting clients' needs. A dynamic organization with an entrepreneurial origin, Everest continues to experience exceptional growth and great success.

Quality is our backbone, customer-focus is our tradition, flexibility is our strength…that's us…that's Everest.

To drive continued success in this exciting clinical research field, we are seeking committed, skilled, and customer-focused individuals to join our winning team as Clinical Data Managers remotely from a home-based office near Warsaw, Poland in accordance with our Work from Home policy.

Key Accountabilities:

• Plan, manage, control, and perform data processing and management activities for assigned projects. These tasks are performed in a timely and accurate manner and in compliance with trial Sponsors’ requirements.
• Lead assigned data processing and management projects by applying project management skills, data processing, and management techniques. Manage timelines and coordinate activities for assigned projects.
• Specify database validation checks for assigned studies. Lead efforts in developing and maintaining standard database validation checks for common modules as well as for therapeutic/drug area specific modules.
• Define and monitor clinical trial dataflow and quality control (QC) processes in accordance to corporate Standard Operating Procedures (SOPs), Good Working Practices, and unit guidelines. Perform clinical trial site monitors' training on dataflow and QC processes.
• Design and review patient Case Report Forms (CRFs) and database schema. Test data capture/entry screens.
• Accurately and efficiently validate electronically captured data. Write clear queries on missing data and data points failing pre-defined range checks and/or logical checks. Lead efforts in building a standard query library for common database modules, as well as for therapeutic/drug area specific modules.
• Perform QC procedures on assigned database during the trial and additional database closure checks at the end of the study.
• Train and supervise Data Entry personnel and junior data management personnel on study procedures, study specific 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 resulting from the coding of medical events, treatment procedures, and medications.
• Maintain and prepare for final archival of data management documentation relevant to the assigned clinical trials and assist the corporate archivist in assembling and archiving clinical trial data and study documentation.
• Cooperate with and assist, when required, data management quality assurance (QA) personnel in performing QA procedures on trial CRFs, database schema, and databases for assigned studies.

Qualifications and Experience:

• A Bachelors' degree in health and/or pharmaceutical sciences, physical/biological, or chemistry fields with at least 2 years experience in clinical trial data capture and management, or a Master's or Ph.D degree in these fields with at least 1 year relevant experience.
• In-depth understanding of clinical trial data management concepts, processes and procedures, relevant issues related to or impacting clinical data management, as well as 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.

To find out more about Everest Clinical Research and to review other opportunities, please visit our website at www.ecrscorp.com

We thank all interested applicants, however, only those selected for an interview will be contacted.

Everest is committed to upholding the principles of dignity, independence, integration, and equal opportunity. We welcome and encourage applications from people with disabilities, and upon request we will provide accommodations for candidates participating in any part of our recruitment and selection process.