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Clinical Research Associate / Senior Clinical Research Associate
Novo Nordisk. Oversee and manage assigned clinical trial sites from start-up to inspection readiness .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical trial management, including oversight of trial sites, adherence to ICH-GCP and regulatory requirements, and effective stakeholder communication. Proven ability to mentor junior staff and manage complex trials while ensuring high-quality execution and compliance.
Highest-signal resume keywords
Clinical Trial MonitoringICH-GCP KnowledgeEDC ProficiencyRisk ManagementStakeholder Management
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 MethodologyData CleaningAdverse Event ManagementSite Performance OversightProtocol Training
Soft Skills
Excellent CommunicationOrganisational SkillsProblem-SolvingDecision-MakingTime Management
Tools & Technologies
EDCCTMSETMF
Industry Keywords
Life SciencesPharmaceutical IndustryCRORegulatory RequirementsInspection Readiness
About the role
Key responsibilities & impact- Oversee and manage assigned clinical trial sites from start-up to inspection readiness
- Serve as the primary liaison between Novo, clinical sites and cross-functional study teams
- Conduct on-site and remote monitoring visits according to the Monitoring Plan, Protocol, ICH-GCP, internal SOPs and regulatory requirements
- Monitor site data, resolve discrepancies and manage adverse events
- Meet data cleaning timelines set out in the Data Flow Plan
- Drive risk-based quality management by identifying, assessing and mitigating risks
- Oversee site performance, recruitment, retention and data collection
- Resolve site-level issues before they affect timelines or quality
- Manage investigational medicinal product, supplies, equipment and essential documents, including the Investigator Trial Master File
- Keep sites inspection-ready
- Lead site training on protocols, procedures and systems
- Share site insights informing protocol updates, patient engagement initiatives and operational planning
- At Sr. CRA level, mentor less experienced CRAs and manage complex trials and operational challenges
- May act as lead CRA, take on a partial trial manager role and represent the local clinical organisation in meetings and working groups
Requirements
What you’ll need- Bachelor’s degree, at minimum, in Life Sciences or a related field
- 5+ years’ experience in clinical trial monitoring or a relevant pharmaceutical industry or CRO role
- Strong knowledge of ICH-GCP, regulatory requirements and clinical trial methodology
- Track record of high-quality, compliant trial execution
- Excellent communication and stakeholder management skills
- Strong organisational, time and project management skills
- Sound problem-solving and decision-making skills
- Proactive risk identification and mitigation
- Confidence with EDC, CTMS, eTMF and other clinical trial software
- Ability to work independently and as part of a team in a dynamic environment
- Flexibility to travel as required
Benefits
Comp & perks- Hands-on trial experience
- CRA training sessions
- Learning from colleagues
- Opportunities to mentor others and take on lead roles
- Supportive team environment
- Professional growth through increased responsibility
- Flexibility to travel as required