Clinical Trial Operations Manager
1 month ago
We are seeking a highly experienced Senior Clinical Program Manager to join our team at Regeneron Pharmaceuticals, Inc. This role will be responsible for leading the global execution of clinical trials from study design through execution to study close out.
Key Responsibilities:
- Liaise with cross-functional teams to develop and implement study plans and timelines.
- Ensure compliance with regulatory requirements and good clinical practices (GCPs).
- Oversee data management, including data entry, query resolution, and data quality assurance.
- Maintain accurate budget management and scope changes for internal and external studies.
- Collaborate with vendors to ensure timely and cost-effective delivery of services.
- Support site activation and monitoring visits, as well as patient recruitment and retention strategies.
- Develop and oversee implementation of risk assessment and mitigation strategies.
- Escalate issues related to study conduct, quality, timelines, or budget to senior management and other stakeholders.
- Provide input into clinical study report writing and review.
- Assign tasks to clinical project staff and support their deliverables.
Requirements:
- Bachelor's degree in life sciences, biotechnology, or a related field.
- Minimum 8 years of experience in clinical trial operations, including experience developing protocols and key study documents.
- Technical proficiency in trial management software and MS applications.
- Strong budget management experience.
- Advanced negotiation and interpersonal skills.
- Excellent project management skills, cross-functional team leadership, and organizational skills.
- Line management experience.
Salary Range:$120,000 - $180,000 per year.
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