Worldwide Clinical Trials este o organizație globală de cercetare clinică pe bază de contract, care sprijină companiile farmaceutice și de biotehnologie pe parcursul întregului ciclu de dezvoltare a medicamentelor. Cu o experiență de peste 30 de ani, compania oferă servicii de monitorizare clinică, gestionare a datelor, recrutare a pacienților și consultanță de reglementare în domenii terapeutice precum oncologia, cardiologia și bolile rare. Abordarea sa combină expertiza vastă în studiile clinice cu sprijin personalizat și soluții adaptate studiilor complexe.
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.
Descriere
- 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.
Cerințe
- 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.
Beneficii
- 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.