We are seeking a dynamic and experienced Clinical Trial Manager to join our team and lead the execution of our client's innovative clinical trials focused in antibody therapeutics. As a Clinical Trial Manager, you will play a pivotal role in overseeing all aspects of clinical trial operations to ensure successful study completion while maintaining compliance with regulatory standards.
Key Responsibilities:
- Lead the planning, implementation, and management of clinical trials from initiation to closeout, ensuring adherence to timelines, budget, and quality standards.
- Collaborate with cross-functional teams including clinical operations, regulatory affairs, data management, and biostatistics to drive the successful execution of clinical trials.
- Manage relationships with investigational sites, vendors, and external partners to ensure seamless coordination and execution of study activities.
- Monitor trial progress, identify risks, and implement mitigation strategies to ensure timely resolution of issues.
- Prepare and review study documents including protocols, informed consent forms, case report forms, and clinical study reports.
- Oversee site selection, site initiation, monitoring visits, and site closeout activities to ensure compliance with study protocols and regulatory requirements.
- Coordinate and participate in regulatory inspections and audits as needed.
Qualifications:
- Bachelor's degree in life sciences, pharmacy, nursing, or related field; advanced degree preferred.
- Minimum of 5 years of experience in clinical trial management within the pharmaceutical, biotechnology, or CRO industry.
- Strong understanding of GCP, ICH guidelines, and regulatory requirements governing clinical research.
- Proven ability to manage multiple projects simultaneously while maintaining attention to detail and meeting deadlines.
- Excellent communication, interpersonal, and leadership skills with the ability to collaborate effectively across teams.
- Proficiency in Microsoft Office Suite and clinical trial management systems.
If you are a driven and results-oriented professional looking to make a significant impact in the field of clinical research, we encourage you to apply for this exciting opportunity.
