Regulatory Specialist with Expertise in Clinical Trial Logistics
hace 1 mes
Overview
Syneos Health, a leading fully integrated biopharmaceutical solutions organization, is seeking a highly skilled Regulatory Specialist with expertise in clinical trial logistics to join our team. We are passionate about developing our people and creating a culture of inclusivity where everyone feels valued and supported.
Job Summary
We are looking for a detail-oriented and organized individual who can provide quality on deliverables at the country level, following project requirements and applicable country rules. The successful candidate will work within forecasted submission/approval timelines, ensuring compliance with regulations and tracking milestone progress in real-time.
Key Responsibilities
- Provide quality on deliverables at the country level, following project requirements and applicable country rules.
- Work within forecasted submission/approval timelines, ensuring compliance with regulations and tracking milestone progress in real-time.
- Monitor basic financial aspects of projects and ensure discrepancies are escalated in a timely fashion.
- Review and comply with Standard Operating Procedures (SOPs) and Work Instructions (WIs) in a timely manner.
- Ensure all relevant documents are submitted to the Trial Master File (TMF) as per Company SOP/Sponsor requirements.
Required Skills and Qualifications
- Associate's Degree or equivalent combination of education and training.
- Good understanding of clinical trial process across Phases II-IV and ICH GCP.
- Ability to interact effectively and appropriately with investigative site personnel.
- Good organizational skills and attention to detail.
- Ability to take direction from multiple individuals and set priorities accordingly.
- Effective communication skills across multiple functions.
Benefits
We offer a competitive salary, estimated at $70,000 - $90,000 per annum, depending on location and experience. Additionally, we provide a supportive and inclusive work environment, opportunities for career development, and a comprehensive benefits package.
About Syneos Health
Syneos Health is a global company with a presence in over 110 countries. We are committed to accelerating customer success through our innovative approach to clinical development, medical affairs, and commercialization. Our employees are passionate about making a difference in the lives of patients and customers worldwide.
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