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Clinical Trial Manager
hace 5 meses
The Clinical Trial Manager is responsible for supporting the planning and execution of one or more Phase 1-4 clinical research studies. The CTM performs clinical trial related responsibilities to ensure studies are executed with quality and efficiency, on-time, within budget, and in support of company objectives.
Responsabilities:
- Responsible for executing one or more elements of clinical studies in compliance with quality standards (ICH/GCP, Global Regulations, and AbbVie policies and procedures).
- Supports the Study Project Manager in leading the cross functional study team: o -Supports the preparation of Clinical Study Team meetings (Agenda/Minutes) o -Responsible for regular updates to the cross-functional team and stakeholders on study status; ensure our CTMS is up to date
- Supports the development of the clinical study blueprint/protocol and associated systems and documents (Informed consent forms, eCRFs, IRT, CSR)
- Supports the vendor selection, scope development, management and oversight of external vendors in compliance with AbbVie’s processes and procedures and the applicable regulations.
- Responsible for generating the study related training for the study team, study sites, and vendors for assigned studies
- Proactively identify and resolve and/or escalate study related issues
- Participates in process improvement initiatives
- Bachelor’s Degree or OUS equivalent degree required, typically in nursing or scientific field; Registered Nurse licensure with Associate’s Degree in Nursing with relevant experience is also acceptable.
- Must have at least four years of Pharma-related/clinical research related experience and demonstrated a high level of core and technical competencies.
- Possesses good communication skills.
- Preferred exposure to study initiation through study completion.
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