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Senior Clinical Research Associate
Novo Nordisk. Oversee and manage assigned clinical trial sites through on-site and remote monitoring visits .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical trial monitoring, ensuring compliance with ICH-GCP and regulatory requirements while effectively managing site performance and patient safety. Proficient in utilizing EDC, CTMS, and eTMF to support trial execution and continuous improvement.
Highest-signal resume keywords
Clinical Trial MonitoringICH-GCP ComplianceRisk Identification And MitigationEDC, CTMS And eTMF ProficiencyProject Management Skills
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical Trial MethodologyRegulatory RequirementsData CollectionSite Performance TrackingAdverse Event Management
Soft Skills
Organisational SkillsProblem-Solving SkillsCommunication SkillsRelationship BuildingAttention To Detail
Tools & Technologies
EDCCTMSETMF
Industry Keywords
Life SciencesCROPharmaceutical IndustryRBQM PrinciplesPatient Safety
About the role
Key responsibilities & impact- Oversee and manage assigned clinical trial sites through on-site and remote monitoring visits
- Ensure compliance with protocols, ICH-GCP and regulatory requirements
- Apply RBQM principles to identify, assess and proactively mitigate risks
- Track site performance, recruitment, retention and data collection
- Act quickly to keep timelines and quality objectives on track
- Resolve discrepancies and manage adverse events
- Protect patient safety and data integrity
- Keep sites inspection-ready
- Train and support site staff on study protocols, operational procedures, systems and compliance requirements
- Represent Novo at site level
- Build trusted relationships with investigators and site teams
- Collaborate with cross-functional colleagues supporting clinical trial execution
- Contribute to continuous improvement and better ways of working
Requirements
What you’ll need- A bachelor’s degree in Life Sciences or a related field
- 3+ years of experience as a CRA in clinical trial monitoring, or in a relevant pharmaceutical industry or in a CRO
- Strong understanding of ICH-GCP, regulatory requirements and clinical trial methodology
- Track record of delivering high-quality trial activities in line with regulatory requirements and internal SOPs
- Hands-on proficiency with EDC, CTMS and eTMF
- Strong organisational, time and project management skills
- Ability to manage multiple sites and priorities with high attention to detail
- Problem-solving and decision-making skills, including risk identification and mitigation
- Excellent written and verbal communication skills
- Ability to build relationships with internal and external stakeholders
- Ability to work independently and as part of a team in a dynamic environment
- Integrity and focus on quality and patient safety
- Openness to new technologies and digital tools
- Ability to travel up to 70% of the time
Benefits
Comp & perks- Short-term (STI) and/or long-term (LTI) incentives may be included
- Continuous learning
- Career development
- Benefits tailored to your life and career stage
- Relevant learning offerings and training
- New technologies and digital tools development opportunities