Clinical Trial Manager
3 weeks ago
Job Title: Clinical Trial Manager
About Advanced Clinical:
Advanced Clinical is a leading provider of clinical research services, dedicated to delivering high-quality results and exceeding customer expectations. Our team of experts works tirelessly to ensure that our clients receive the best possible support for their clinical trials.
Job Description:
We are seeking an experienced Clinical Trial Manager to join our team in LATAM. As a Clinical Trial Manager, you will be responsible for overseeing clinical trial sites from start-up to close-out, ensuring compliance with the study protocol, ICH guidelines, Good Clinical Practices (GCP), and regulatory requirements.
- Manage clinical trial sites to ensure timely delivery, meet recruitment targets, and produce high-quality data.
- Track site visit metrics, data quality concerns, and protocol deviations; conduct oversight visits for compliance evaluation.
- Review CRA monitoring reports to ensure protocol and operational compliance; escalate issues for resolution.
- Collaborate with teams for efficient study start-up, identifying risks and ensuring timelines are met.
- Act as a subject matter expert on assigned protocols and manage CRO/site during start-up activities, including contract negotiations and document collection.
- Could you provide direction to ensure consistency in Clinical Operations processes across trials and regions?
- Work cross-functionally with departments to meet study requirements and timelines.
- Contribute to developing and reviewing study-related documents and deliver trial-specific training.
- Monitor open action items and data trends, addressing issues with CROs to enhance study execution and efficiency.
Experience:
- Minimum of 5 years of clinical operational experience in biotechnology, pharmaceuticals, and CROs.
- Strong understanding of GCP, ICH, GDP, and relevant CFRs; familiarity with MHRA, EMA, and international regulations is a plus.
- Experience with clinical trial site start-up and initiation.
- Proven ability to build and maintain relationships with clinical trial sites and Principal Investigators.
- Strong communication skills for coordinating activities with internal teams, sites, and vendors.
- Proactive in identifying project challenges and proposing corrective actions with minimal supervision.
- Capable of working independently and delivering high-level presentations.
- Knowledge and experience in oncology.
- Previous experience as a Clinical Research Associate (CRA).
Compensation: $80,000 - $110,000 per year, depending on experience.
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