SR. Clinical Trial Manager/AD, Clinical Operations
4 weeks ago
Are you an experienced Clinical Operations professional looking to advance your career in a dynamic and innovative environment? Do you thrive in a fast-paced setting and excel at managing clinical trials from start to finish? If so, we have an exciting opportunity for you to join a prominent biopharmaceutical company dedicated to advancing novel therapies for patients in need.
Key Responsibilities:
- Lead the planning, execution, and management of clinical trials in accordance with protocol, budget, and timelines.
- Serve as the primary point of contact for clinical sites, CROs, and other external vendors, ensuring effective communication and collaboration throughout the trial lifecycle.
- Oversee the development and implementation of clinical trial protocols, study plans, and operational procedures to ensure compliance with regulatory requirements and industry standards.
- Manage study budgets, resource allocation, and vendor selection to optimize trial efficiency and cost-effectiveness.
- Contribute to the development of clinical trial protocols, informed consent forms, and other study-related documents in collaboration with cross-functional teams.
Qualifications:
- Bachelor's degree in a scientific or healthcare-related field; advanced degree preferred.
- Minimum of 3 years of experience in clinical operations within the biopharmaceutical or pharmaceutical industry, with a focus on managing clinical trials.
- Proven track record of successfully managing multiple clinical trials simultaneously, from initiation to closeout.
- Strong understanding of GCP guidelines, FDA regulations, and other relevant regulatory requirements.
- Excellent communication, leadership, and problem-solving skills, with the ability to work effectively in cross-functional teams.
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