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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in managing clinical trial site relationships and monitoring activities, ensuring compliance with GCP, ICH, and regulatory standards. Proven ability to facilitate effective communication and collaboration among cross-functional teams while maintaining data integrity and patient safety.
Highest-signal resume keywords
Site Monitoring ExperienceKnowledge Of GCP/ICH StandardsClinical Trial ManagementStrong Communication SkillsProblem-Solving 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 MonitoringSite ManagementData IntegrityRegulatory ComplianceProtocol ComplianceTraining DeliveryRisk IdentificationAudit ReadinessNegotiation SkillsTime Management
Soft Skills
CollaborationPresentation SkillsInterpersonal Skills
Industry Keywords
Drug Development ProcessClinical ResearchFDA RegulationsEMEA GuidelinesSite Initiation Visits
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Manage trusted site relationships and perform on-site and remote monitoring activities for Phase I–IV clinical trials
- Serve as the primary site manager and first point of contact between site staff and Novartis
- Support collaboration, milestones, and deliverables as a frontline liaison
- Monitor according to legislation, ICH/GCP, Novartis standards, monitoring plans, and procedures
- Conduct site initiation visits and deliver ongoing training for site personnel
- Perform continuous on-site and remote monitoring for protocol, GCP, regulatory, process compliance, data integrity, and patient safety
- Facilitate preparation and collection of site- and country-level documents
- Identify risks, resolve issues, and escalate concerns as needed
- Collaborate with cross-functional teams to drive efficient study execution and process improvements
- Deliver timely, high-quality, robust, reliable site data supporting Trial Monitoring goals
- Partner with the SSU CRA for seamless transition of site responsibility
- Act as a subject matter expert across study activities when required
- Support audit and inspection readiness activities and corrective-action implementation
- Drive clinical trials forward at the site level with patients at the center
Requirements
What you’ll need- Minimum of 3 years’ experience in site monitoring
- BS/BA degree in a scientific, healthcare, or related field
- Excellent knowledge of the drug development process, specifically clinical trial/research
- Knowledge of international standards (GCP/ICH, FDA, EMEA)
- Ability to manage multiple priorities and manage time efficiently
- Excellent site management capabilities with demonstrated negotiating and problem-solving skills
- Strong communication and presentation skills, oral and written
- Fluent in both written and spoken English
- Fully valid and unrestricted driver’s license
- Ability to be located in the western region of the United States near a major airport, preferably in California, Washington State, Oregon, or Nevada
- Ability to travel 80%
Benefits
Comp & perks- Performance-based cash incentive
- Eligibility to be considered for annual equity awards, depending on the level of the role
- Health benefits
- Life benefits
- Disability benefits
- 401(k) with company contribution and match
- Vacation
- Personal days
- Holidays
- Other leaves
- Reasonable accommodations for qualified individuals with disabilities
