Clinical Trial Operations Manager
19 ore fa
At Mil Fortrea Clinical Development Ltd Filiale Italiana, we are seeking a skilled Clinical Trial Operations Manager to oversee local deliverables and ensure seamless execution of clinical trials. This role is ideal for individuals with a passion for scientific rigor and experience in managing country-specific trial commitments.
About the RoleThis position requires a strong understanding of local regulations, laws, and procedures, as well as excellent communication skills to effectively collaborate with internal and external stakeholders. The successful candidate will be responsible for executing and overseeing clinical trial country submissions and approvals, developing local language materials, and ensuring compliance with ICH Guidelines and GCP.
Key Responsibilities- Execute and oversee clinical trial country submissions and approvals for assigned protocols.
- Develop local language materials, including local language Informed Consents and translations.
- Maintain expertise in local regulations, laws, and procedures, with minimal support from client management.
- Collaborate closely with internal teams, vendors, sites, IRB/IECs, and Regulatory Authorities to ensure country deliverables are obtained.
- University degree (life science preferred) or certification in a related allied health profession.
- Minimum 4-6 years of clinical research experience in pharmaceutical or CRO industries.
- Thorough knowledge of ICH Guidelines and GCP, including local regulatory requirements.
- Excellent communication and organizational skills, with the ability to work under pressure to meet deadlines.
- Familiarity with investigator start-up documents and previous interaction with operational project teams and investigative sites.
We offer a competitive salary range of $80,000-$110,000 per annum, depending on experience, plus benefits and opportunities for professional growth and development. If you are a motivated problem-solver with a passion for overcoming barriers in clinical trials, we encourage you to apply for this exciting opportunity.
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