Clinical Data Coordinator

Barrington James; United States; À distance; USD 65 000 - 90 000; Plein temps

Résumé du poste

Barrington James partnered CRO seeks an experienced Clinical Data Coordinator to join their Data Management team in a fully remote role. The position offers exposure to a varied portfolio of clinical studies in a collaborative environment.

You will support day-to-day data management, perform data review and cleaning, and coordinate with sites and vendors. Strong CRO and EDC experience are essential.

Qualifications

• Bachelor’s degree in life sciences, health sciences, pharmacy or a related field.
• 1+ years of clinical data management or clinical data coordination experience within pharmaceutical, biotech or CRO settings.
• CRO experience (required).
• Hands-on experience with EDC systems such as Medidata Rave, Veeva Vault CDMS, Oracle InForm or similar.
• Working knowledge of GCP, ICH guidelines and CDISC/CDASH standards.
• Strong attention to detail, organization and the ability to manage multiple studies and deadlines.

Responsabilités

• Support day to day clinical data management activities across assigned studies, ensuring data is accurate, complete and compliant throughout the study lifecycle.
• Perform data review and cleaning, generating, issuing and resolving queries with sites in line with the Data Management Plan and study timelines.
• Assist with database setup and user acceptance testing (UAT), including review of CRF/eCRF designs, edit check specifications and completion guidelines.
• Reconcile external and third-party vendor data (e.g. lab, ECG, IRT) and SAE data against the clinical database.
• Maintain study documentation and Trial Master File records, ensuring all work follows SOPs, GCP and regulatory requirements.
• Track and report data management metrics, communicating progress, issues and risks to the Clinical Data Manager and wider study team.
• Support interim analyses, database lock activities, and client audits or inspections as needed.

Connaissances

Bachelor's degree in life sciences, a

1+ years clinical data management

CRO experience

EDC systems (Medidata Rave, VeevaVault

GCP/ICH/CDISC/CDASH

Attention to detail & multi-study mgmt

Formation

Bachelor’s degree in life sciences health sciences pharmacy or related field

Outils

Medidata Rave

Veeva Vault CDMS

Oracle InForm

Description du poste

Barrington James is proud to partner with a highly respected, well established CRO seeking an experienced Clinical Data Coordinator to join their growing Data Management team. This is an excellent opportunity to work on a varied portfolio of clinical studies in a collaborative, supportive environment, fully remote.

Key Responsibilities:

• Support day to day clinical data management activities across assigned studies, ensuring data is accurate, complete and compliant throughout the study lifecycle.
• Perform data review and cleaning, generating, issuing and resolving queries with sites in line with the Data Management Plan and study timelines.
• Assist with database setup and user acceptance testing (UAT), including review of CRF/eCRF designs, edit check specifications and completion guidelines.
• Reconcile external and third-party vendor data (e.g. lab, ECG, IRT) and SAE data against the clinical database.
• Maintain study documentation and Trial Master File records, ensuring all work follows SOPs, GCP and regulatory requirements.
• Track and report data management metrics, communicating progress, issues and risks to the Clinical Data Manager and wider study team.
• Support interim analyses, database lock activities, and client audits or inspections as needed.

Qualifications & Skills:

• Bachelor’s degree in life sciences, health sciences, pharmacy or a related field
• 1+ years of clinical data management or clinical data coordination experience within pharmaceutical, biotech or CRO settings
• CRO experience (required)
• Hands-on experience with EDC systems such as Medidata Rave, Veeva Vault CDMS, Oracle InForm or similar
• Working knowledge of GCP, ICH guidelines and CDISC/CDASH standards
• Strong attention to detail, organization and the ability to manage multiple studies and deadlines