Clinical Trial Operations Specialist
hace 9 horas
As a global leader in clinical development, Fortrea provides innovative solutions to pharmaceutical, biotechnology, and medical device companies across 20+ therapeutic areas.
We are seeking an experienced Clinical Trial Operations Specialist to join our team. This role will be responsible for executing and overseeing local operational clinical trial activities, ensuring compliance with regulatory requirements and financial targets.
This is a critical position that will have a significant impact on how our company delivers country-specific trial commitments and objectives. The successful candidate will work closely with internal stakeholders, vendors, external partners, and country managers to ensure timely delivery of clinical trials.
The key responsibilities of this role include:
- Assistance with country and site budget ownership
- Delivering clinical and financial contracts within fair market value
- Oversight and tracking of clinical research-related payments
- Payment reconciliation at study close-out
In addition, the Clinical Trial Operations Specialist will be responsible for:
- Executing and overseeing clinical trial country submissions and approvals
- Developing local language materials, including informed consents and translations
- Collaborating with IRB/IEC and Regulatory Authorities
The ideal candidate will have a university degree in life sciences or a related field, or equivalent experience in clinical research. They will also possess excellent communication and organizational skills, with the ability to work independently and as part of a team.
A minimum of 2-3 years of experience in clinical trial operations is required, with a thorough understanding of ICH guidelines, GCP, and local regulatory requirements. Fluency in English and the local office language is essential.
We offer a competitive salary of $80,000 - $110,000 per year, depending on experience, plus benefits and opportunities for professional growth.
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