Clinical Data Coordinator

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

Benefits

• Fully remote; US based.
• Glassdoor
• 3.2
• Life sciences executive recruitment and staffing services.
• Crawley, West Sussex, GBR
• https://barringtonjames.com/
• Growth Stage
• Total Funding
• unknown
• Key Investors
• Orangewood Partners
• 2022-10-05
• Private Equity
• Recent News
• PharmiWeb.com
• Weekly Pharma & Life Science News Round-Up: 10th-14th October
• 2022-10-14
• Orangewood Partners Makes Strategic Investment in Barrington James
• 2022-10-06
• Company data provided by
• AI Tools
• Customize Your Resume
• Maximize your interview chances
• Build Cover Letter
• Make your application stand out
• Analyze How Well You Fit
• Understand your strength & weakness

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

Required skills

• CDASH Standards, CDISC Standards, CRO Experience, Clinical Data Management, Clinical Practice (GCP), ICH Guidelines, Medidata Rave, Oracle InForm, Veeva Vault CDMS

Experience

• 1+ years