Worldwide Clinical Trials je globalna pogodbena raziskovalna organizacija, ki farmacevtskim in biotehnološkim podjetjem pomaga v celotnem življenjskem ciklu razvoja zdravil. Podjetje ima več kot 30 let izkušenj ter zagotavlja klinično spremljanje, upravljanje podatkov, pridobivanje bolnikov in regulativno svetovanje na terapevtskih področjih, vključno z onkologijo, kardiologijo in redkimi boleznimi. Njegov pristop združuje široko strokovno znanje o kliničnih preskušanjih s prilagojeno podporo in rešitvami, oblikovanimi za kompleksne študije.
Senior Oncology Clinical Trial Manager – Europe (Remote)
Lead oncology site management across Europe at Worldwide Clinical Trials, a global contract research organization. Oversee monitoring, regulatory compliance, recruitment, risk management, and study teams.
Opis
- Oversee clinical site management from study startup through database lock and closeout.
- Work with project management to set monitoring strategies and site targets, and deliver on project goals.
- Guide and oversee CRAs and site management staff across assigned studies and regions.
- Represent site management with sponsors and study teams, including at investigator meetings, audits, inspections, and project discussions.
- Maintain quality and compliance by overseeing monitoring, reviewing protocol deviations, following Clinical Monitoring Plans, and ensuring inspection readiness.
- Track study metrics, recruitment, resources, and operational trends to identify risks and put solutions in place.
- Track enrollment and guide site-specific strategies to support patient recruitment.
- Maintain Trial Master File compliance and ensure site management documents are completed promptly and reviewed for quality.
- Identify, escalate, and reduce operational and monitoring risks; help resolve issues and improve processes.
- Coordinate with project teams, sponsors, CRAs, and cross-functional colleagues across time zones.
Zahteve
- A four-year college curriculum or equivalent, with a major in biological, physical, or health studies, plus at least four years of experience as a Senior Clinical Research Associate or equivalent; OR
- A two-year college curriculum or equivalent education or training, plus at least six years of experience as a Senior Clinical Research Associate and at least two years of relevant experience as a CTM/LCRA or equivalent, including oversight of a CTM team.
- A nursing or equivalent life sciences degree is preferred.
- Oncology study experience is required.
- Experience leading or coordinating clinical monitoring and site management for clinical trials.
- Strong understanding of clinical research principles, site management processes, and monitoring practices.
- Knowledge of FDA and/or EU regulations, ICH Guidelines, local regulatory requirements, and clinical trial SOPs.
- Experience reviewing study metrics, managing operational risks, supporting recruitment, and maintaining high-quality study documentation.
- Proficiency with Microsoft Office and clinical systems such as EDC, CTMS, IxRS/IVRS, and eCRF platforms.
- Ability to lead and motivate remote teams, influence stakeholders, solve complex problems, and manage competing priorities.
- Proficiency in English, with excellent written, verbal, presentation, and interpersonal communication skills.
Ugodnosti
- Equal employment opportunity.
- A diverse and inclusive workplace.
- Accessible, hands-on leaders.
- Cohesive and supportive teams.
- Support for professional growth and success.
- Remote work arrangement.
- Travel as needed.