Global Clinical Operations Specialist
hace 23 horas
Company Overview:
Ingepsy, a leading global contract research organization (CRO), is dedicated to advancing healthcare and improving lives through its commitment to scientific rigor and clinical development expertise.
We provide pharmaceutical, biotechnology, and medical device customers with a wide range of clinical development solutions across more than 20 therapeutic areas. Our team of over 19,000 staff members conducts operations in more than 90 countries, transforming drug and device development for partners and patients worldwide.
About the Role:
We are seeking an experienced Centralized Study Specialist I to join our team. As a key member, you will play a pivotal role in the successful execution of clinical trials and contribute to process improvement initiatives.
Job Description:
- Clinical Systems Management: Manage clinical systems, maintain study databases (CTMS, IWRS, EDC, etc.), support eTMF management.
- Study Coordination: Track CRAs on outstanding issues, generate study-specific reports, manage internal and external communications, ensure training compliance, and assist in managing study payments.
- Data Review: Follow up with CRAs on resolution of outstanding issues/action items, perform Associate Lead/Lead role for assigned projects, draft and send study-specific reports, collaborate with Data Management and Programming teams.
- Study Support: Generate and analyze study reports, manage access on applicable study systems, set up study systems for newly awarded studies, ensure CTMS compliance, manage project communications, and assist project teams with study support activities.
Required Skills and Qualifications:
- Education: University/College Degree in Life Sciences or related field, or certification in an allied health profession from an accredited institution.
- Experience: 2-3 years of work experience in clinical research, strong working knowledge of ICH-GCP guidelines, and relevant regulations.
- Skills: Demonstrated ability to plan, prioritize, organize, and communicate effectively; attention to detail; strong interpersonal skills; ability to lead process improvement initiatives and mentor others.
Benefits and Salary:
This role comes with a competitive salary of $85,000 - $110,000 per year, depending on qualifications and experience. Additionally, Ingepsy offers a comprehensive benefits package, including medical, dental, and vision insurance, 401(k) matching, paid time off, and opportunities for professional growth and development.
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