Clinical Data Associate – EDC, Data Review & Reconciliation 3671407

Axiom Path, Inc.; United States; On-site; USD 85,000 - 125,000; Full time

Job summary

Axiom Path is seeking a detail-oriented Clinical Data Manager to join a fully remote team supporting active clinical development programs in the U.S. You will collaborate with Lead Data Managers and contribute to the quality, integrity, and readiness of study data across multiple studies.

The role focuses on day-to-day data management activities, data review, discrepancy management, and preparation of data listings and documentation.

Qualifications

• Associate degree or higher required.
• Minimum 2 years of clinical data management experience within a pharmaceutical, biotechnology, or CRO environment preferred.
• 3–5 years of relevant experience are particularly well aligned with the scope of the role.
• Hands-on experience working within an EDC system.
• Medidata Rave experience strongly preferred and highly relevant to success in the role.
• Experience performing clinical data review and discrepancy/query management.
• Experience with data reconciliation and review of clinical data listings.
• Familiarity with standard Data Management study documents, including Data Management Plans and data review/quality plans.
• Strong attention to detail and ability to identify inconsistencies in clinical data and study documentation.
• Strong written and verbal communication skills.
• Ability to work independently while taking direction from a Lead Data Manager.
• Ability to collaborate effectively within a fully remote, cross-functional study environment.

Responsibilities

• Support Lead Data Managers with day-to-day activities across assigned clinical studies.
• Perform clinical data review and identify discrepancies requiring clarification or follow-up.
• Manage discrepancies and support resolution of clinical data issues within the EDC environment.
• Generate and review data listings used for study review and reconciliation activities.
• Perform clinical data reconciliation and track issues through resolution.
• Update or perform quality-control review of study Data Management documentation.
• Support documents such as Data Management Plans and data quality or review plans.
• Run and review study metrics and database outputs for Lead Data Managers.
• Perform database and documentation QC to ensure accuracy and consistency.
• Follow established Data Management procedures, study requirements, GCP expectations, and applicable regulations.
• Work closely with Lead Data Managers and cross-functional study partners to maintain high-quality clinical data.

Skills

Clinical data management

Discrepancy/query management

Attention to detail

Written and verbal communication

Independent work

Remote cross-functional collaboration

EDC experience

Data listing review

Education

Associate degree or higher

Tools

Medidata Rave

EDC systems

Job description

Be Part Of A High-Performing Team

Join a collaborative clinical data management organization supporting active clinical development programs across multiple study teams. The group works in a fully remote environment and brings together data management professionals across different U.S. time zones. This position will work closely with experienced Lead Data Managers and contribute directly to the quality, integrity, and readiness of clinical study data.

The role will support growing study workloads and may contribute to pulmonary-focused clinical development programs. Candidates do not need prior experience in a specific therapeutic area, as study protocols and indication-specific requirements will be covered through training.

What's In Store For You

• Fully remote opportunity with team members working across multiple U.S. time zones.
• Flexibility in daily scheduling, provided required core-team meetings and study obligations are supported.
• Opportunity to work directly with experienced Lead Data Managers across active clinical studies.
• Initial 12-month engagement with strong potential for extension based on ongoing program needs.
• Engagement: W2 only (no C2C/1099).

How You Will Make An Impact

• Support Lead Data Managers with day-to-day activities across assigned clinical studies.
• Perform clinical data review and identify discrepancies requiring clarification or follow-up.
• Manage discrepancies and support resolution of clinical data issues within the EDC environment.
• Generate and review data listings used for study review and reconciliation activities.
• Perform clinical data reconciliation and track issues through resolution.
• Update or perform quality-control review of study Data Management documentation.
• Support documents such as Data Management Plans and data quality or review plans.
• Run and review study metrics and database outputs for Lead Data Managers.
• Perform database and documentation QC to ensure accuracy and consistency.
• Follow established Data Management procedures, study requirements, GCP expectations, and applicable regulations.
• Work closely with Lead Data Managers and cross-functional study partners to maintain high-quality clinical data.

Do You Bring Proven Success in Clinical Data Management and Medidata Rave?

• Associate degree or higher required.
• Minimum 2 years of clinical data management experience within a pharmaceutical, biotechnology, or CRO environment preferred.
• Candidates with approximately 3--5 years of relevant experience are particularly well aligned with the scope of the role.
• Hands-on experience working within an EDC system.
• Medidata Rave experience strongly preferred and highly relevant to success in the role.
• Experience performing clinical data review and discrepancy/query management.
• Experience with data reconciliation and review of clinical data listings.
• Familiarity with standard Data Management study documents, including Data Management Plans and data review/quality plans.
• Strong attention to detail and ability to identify inconsistencies in clinical data and study documentation.
• Strong written and verbal communication skills.
• Ability to work independently while taking direction from a Lead Data Manager.
• Ability to collaborate effectively within a fully remote, cross-functional study environment.