The CTOM is the single point of contact for Functional Service Provider (FSP) vendors for resource and capacity management, portfolio planning and prioritization, including the identification, escalation and resolution of quality and delivery issues in Iberia. Performs oversight activities of FSP staff including CRA and CTA performance, delivery and quality metrics in collaboration with FSP Line Managers. Conducts on-site quality visits with CRAs where/when appropriate and supports maintenance of Amgen investigator site relationships. Engage local cross-functional teams (Medical, Regulatory, Legal, Compliance) to maximize local support of clinical trials;
Oversight of the site contracting/budgeting activity in Iberia: CTOM supervises staff involved in local site contracting and budget management, insurance and payment process (as Line Manager of 4 people).
Actively participates in Global CTOM Forum including local and global functional and cross-functional initiatives;
BA/BS/BSc in sciences. >5 years experience working in clinical site management (working on clinical trials at a biotech, pharmaceutical or CRO);
Preferred experience >2 years in a project leadership role.
Extensive knowledge of ICH/GCP regulations and guidelines;
Strong knowledge of clinical trial operations;
Understanding of Functional Service Provider operational model;
Relevant therapeutic area education and training.
Ability to work effectively in a team/matrix environment on multiple projects;
Ability to lead and influence in a positive manner;
Strong decision-making authority;
Strong interpersonal skills;
Excellent organizational and planning skills;
Attention to quality metrics and study deliverables;
Strong issue and risk management capability;
Demonstrated ability to anticipate and resolve problems.