GCP Quality Data Specialist

Dashboard Visionary Operations Data Entry Innovation Data Analysis Biotechnology Storyboarding Medidata Rave Data Integrity Reconciliation Pharmaceuticals Clinical Trials Data Management Clinical Research Quality Assurance Regulatory Affairs Root Cause Analysis Clinical Monitoring Clinical Data Review Pivot Tables And Charts Pre-Clinical Development Clinical Data Management Engineering Design Process Training Records Management Clinical Trial Management Systems Corrective And Preventive Action (CAPA)

At least 3 years $114,400 - $135,200 / yr Posted yesterday, The GCP Clinical Quality Data Specialist will provide independent Quality Assurance oversight of clinical studies supporting the sponsor company’s clinical development portfolio. The individual will review clinical data and study documentation from a quality and compliance perspective, identify emerging trends or GCP risks, and help ensure issues are appropriately escalated, investigated, corrected, and tracked to closure., * Perform independent, risk-based quality reviews of clinical trial data and study documentation.

• Review listings, data, eligibility, dosing, adverse events, serious adverse events, concomitant medications, and chain-of-identity information.
• Review and trend protocol deviations across studies, sites, and vendors.
• Identify recurring or systemic quality risks and support root-cause analysis, CAPA development, effectiveness checks, and closure.
• Build or maintain key quality indicators, dashboards, and trend reports.
• Support oversight of CROs, clinical vendors, eClinical providers, central laboratories, and specialty laboratories.
• Review data management plans, reconciliations, transfer specifications, vendor deliverables, and performance metrics.
• Conduct eTMF quality checks for completeness, timeliness, accuracy, and inspection readiness.
• Review study-related training records and identify documentation gaps.
• Support site, vendor, internal process, and regulatory inspection activities.
• Assist with inspection data requests, storyboards, data pulls, and back-room support.
• Support data-integrity assessments and audit-trail reviews.
• Contribute to SOPs, work instructions, and training associated with clinical data review and quality oversight.
• Partner with Clinical Operations, Clinical Quality, Regulatory Affairs, data-focused functions, vendors, and study stakeholders.

Essential Skills

• GCP and clinical quality compliance: Apply ICH E6 GCP principles.
• Hands-on clinical data review: Review listings, data, eligibility, dosing, concomitant medications, adverse events, serious adverse events, and chain-of-identity information.
• Protocol deviation oversight: Review deviation classification and identify trends.
• Inspection readiness: Maintain an inspection-ready state and support inspection activities.
• CRO and vendor oversight: Evaluate CROs, eClinical vendors, central laboratories, and specialty laboratories.
• TMF quality: Review eTMF for completeness, timeliness, accuracy, and overall health.
• Quality metrics and trending: Build or maintain key quality indicators, dashboards, and trend reports.
• Excel and data analysis: Use pivot tables, lookups, filters, and related functions.
• Data integrity: Support audit-trail reviews and assessments.
• Clear escalation: Document observations objectively and communicate findings.

• At least 3 years of clinical research experience in a biotechnology, pharmaceutical, or CRO environment.
• At least 2 years in Clinical Quality Assurance, Clinical Data Management, Clinical monitoring, or Centralized monitoring.
• Working knowledge of GCP and clinical-trial requirements.
• Experience working with clinical data listings, reconciliation reports, study-level metrics, or quality data.
• Experience with CROs and outsourced clinical vendors.
• Understanding of TMF quality and inspection-readiness expectations.
• Ability to identify patterns, inconsistencies, and potential compliance risks.
• Strong written documentation and escalation skills.
• Ability to manage multiple studies and shifting priorities.
• Pivotal or registrational trial experience.
• Inspection-readiness experience.
• Experience using platforms such as Medidata Rave is preferred.
• Independent judgment rather than routine data entry or checklist-only QC., Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.