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About the role
Key responsibilities & impact- Serve as the main client point of contact for investigative sites throughout the study lifecycle
- Manage site start-up activities through activation
- Build and retain investigator site relationships and provide support from site recommendation through study closeout
- Support country and site selection activities by providing local intelligence and collaborating with stakeholders
- Conduct site-level start-up activities, including PTA, activation checklist coordination, ICD finalization, and SIV as applicable
- Coordinate site initiation training and collect or complete required activation documentation and systems
- Ensure site readiness for first subject first visit in partnership with site monitors
- Coordinate resolution of escalated site issues, including vendor, contracts, and payment issues
- Support investigational product and ancillary supply strategies throughout the study lifecycle
- Plan and support site recruitment, enrollment, and investigator responses to recruitment issues
- Maintain regular communications with investigator sites and track recruitment, data entry, performance metrics, and study feedback
- Coordinate country or local registry completion with local RA, CTRO, and SAP stakeholders
- Act as the operational point of contact for site-level questions and escalate issues as appropriate
- Review site monitoring reports and support ICD document revisions and submissions
- Maintain site-level systems and alignment across EDC, Shared Investigator Platform, Site Profile, and other applicable systems
- Review and update Site Management Organization Assessments and continuity or contingency plans
- Manage site practices that differ from client practices and liaise with study management and process owners
- Oversee site deliverables including data cuts, interim analyses, database locks, and investigator signatures
- Follow study oversight plans and implement risk mitigations
- Support decentralized capabilities such as home health, ePRO, and DTP
- Assure quality and consistency of monitoring delivery and drive efficiencies and best practices
- Support positive investigator relationships and escalate training or compliance concerns
- Provide local intelligence and input into site recommendations and performance metrics
- Support local requirements for importation and exportation of investigational products and ancillary supplies
Requirements
What you’ll need- Ability to communicate effectively and appropriately with internal and external stakeholders
- Ability to adapt to changing technologies and processes
- Demonstrated networking and relationship-building skills
- Ability to manage cross-functional relationships
- Demonstrated experience in site management with prior experience as a site monitor
- Demonstrated experience in full lifecycle activities from start-up/site activation through closeout
- Demonstrated knowledge of quality and regulatory requirements for the country the role is based
- Knowledge of Good Clinical Practice (GCP), International Council for Harmonization (ICH) Guidelines, and other applicable regulatory requirements
- Ability to manage required travel of up to 50% on a regular basis
- Proficiency in the local language
- English is required
- Bachelor’s degree or RN in a related field, or equivalent combination of education, training, and experience
- At least 5 years’ experience estimated for the equivalent combination pathway
Benefits
Comp & perks- Remote work arrangement
- Full-time employment