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Clinical Research Associate
Novo Nordisk. Oversee assigned trial sites from monitoring through to inspection readiness.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical trial monitoring, including strong knowledge of ICH-GCP guidelines and regulatory requirements. Capable of managing multiple sites while maintaining high-quality trial execution and fostering relationships with stakeholders.
Highest-signal resume keywords
Clinical Trial MonitoringICH-GCP GuidelinesProject ManagementRisk-Based Quality Management (RBQM)EDC Systems
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
Clinical Trial MethodologyRegulatory RequirementsData ReviewAdverse Event ManagementSite Performance TrackingData CleaningInspection ReadinessProtocol TrainingInvestigator Trial Master File ManagementAudit Support
Soft Skills
Organisational SkillsTime ManagementCommunicationProblem-SolvingRelationship Building
Tools & Technologies
CTMSETMFDigital Trial Tools
Industry Keywords
Life SciencesPharmaceutical IndustryCROSite LiaisonStakeholder Engagement
About the role
Key responsibilities & impact- Oversee assigned trial sites from monitoring through to inspection readiness.
- Act as the primary liaison between Novo, clinical sites and cross-functional study teams.
- Build strong relationships with investigators and site staff.
- Conduct on-site and remote monitoring visits in line with the Monitoring Plan, Protocol, ICH-GCP, internal SOPs and regulatory requirements.
- Review site data, resolve discrepancies, manage adverse events and keep data cleaning on track.
- Track site performance, recruitment and retention.
- Resolve site-level issues early to keep timelines and quality on target.
- Apply RBQM principles to identify, assess and reduce risks.
- Maintain inspection readiness and support audits and inspections.
- Train and support sites on protocols, procedures and systems.
- Manage investigational medicinal product, study supplies, essential documents and the Investigator Trial Master File.
- Share site feedback and insights to improve protocols, patient engagement and operational planning.
- Work with investigators, study nurses, coordinators, pharmacists, key opinion leaders, vendors and internal cross-functional teams.
- Report to a Clinical Operations Manager.
Requirements
What you’ll need- A bachelor’s degree in Life Sciences or a related field.
- 1+ years’ experience in clinical trial monitoring, or in a relevant pharmaceutical industry or CRO role.
- Strong knowledge of ICH-GCP guidelines, regulatory requirements and clinical trial methodology.
- Track record of compliant, high-quality trial execution.
- Strong organisational, time management and project management skills.
- Ability to manage multiple sites and priorities with close attention to detail.
- Confidence using digital trial tools, including EDC systems, CTMS and eTMF.
- Excellent written and verbal communication.
- Ability to build trusted relationships with internal and external stakeholders at all levels.
- Proactive approach to problem-solving, risk identification and decision-making.
- Ability to work independently and as part of a team.
- Flexibility to travel to sites as required.
- Fluency in French and professional English.
- Hands-on experience applying risk-based quality management (RBQM) principles in study conduct is useful, but not essential.
- Experience supporting audits or regulatory inspections is useful, but not essential.
Benefits
Comp & perks- Short-term and/or long-term incentives
- Other employee benefits based on position level, location, functional area and relevant market benchmarks
- Investigator meetings
- CRA training sessions
- Opportunities to explore new technologies and digital tools
- Clear performance expectations and recognition for strong performance