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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive clinical research experience with a strong understanding of the drug development process, ICH/GCP regulations, and effective project management skills. Capable of managing investigator relationships and ensuring successful clinical trial oversight while maintaining high levels of communication and collaboration.
Highest-signal resume keywords
Clinical Research ExperienceProject Management SkillsICH/GCP KnowledgeSponsor Oversight ActivitiesCross-Functional Drug Development
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 ManagementInvestigator Engagement StrategiesCo-Monitoring TasksTrial Progress MonitoringSite Selection Process
Soft Skills
Strong Communication SkillsInterpersonal SkillsCultural AwarenessCustomer-Focused
Tools & Technologies
IT Tools for Virtual Team Collaboration
Industry Keywords
Clinical Operational ActivitiesOutsourced/FSP ModelSponsor Oversight VisitsCountry Regulations
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Maintain and update local knowledge of therapeutic and disease areas researched by Biogen
- Manage investigator and site relationships to highlight country-level capabilities and satisfaction levels
- Develop and execute country-level QSDO investigator engagement strategies
- Support local activities in the country and site selection process
- Act as primary country-level QSDO/Biogen contact for sponsor oversight of CRO and clinical trial activities
- Perform co-monitoring tasks during Sponsor Oversight Visits (SOVs)
- Lead interactions for timely local information flow with Investigators and affiliate office staff
- Monitor and analyze overall trial and country progress to support QSDO deliverables
- Support local projects or other CSO activities as a representative of the country
- Serve as a site escalation point for investigator concerns and communicate unresolved issues to the appropriate Biogen party
Requirements
What you’ll need- Minimum 5 years clinical research experience
- Experience managing clinical trial activities, especially sponsor oversight activities
- Understanding of cross-functional drug development process and high scientific/clinical knowledge
- Knowledge of ICH/GCP and applicable country regulations
- Strong organizational and project management skills
- Effective working knowledge of relevant IT tools for virtual team collaboration
- Excellent knowledge of clinical operational activities across local geography
- Strong communication skills, including English proficiency in non-English speaking countries
- Experience in an outsourced/FSP model with CROs/vendors preferred
- Customer-focused with excellent interpersonal skills and cultural awareness preferred
- Proven ability to handle tasks of varying complexity within a given timeframe preferred
Benefits
Comp & perks- Opportunities for learning, growth, and expanding skills
- Stability and resources of a well-established biotechnology company
- Inclusive and belonging-focused culture
- Employee contributions with significant impact
- Work together to deliver life-changing medicines
