Clinical Trials Operations Manager
2 weeks ago
Job Title: Clinical Trials Operations Manager
Location: Remote
Job Overview:
As the Clinical Trials Operations Manager, you will be responsible for overseeing the operational aspects of clinical trials. Your role is crucial in ensuring that recruitment goals, timelines, budgets, and quality standards are met throughout the trial process.
Key Responsibilities:
- Lead the local trial team to maintain the integrity of trial execution, ensuring patient safety and compliance with regulatory standards.
- Coordinate with various functions and stakeholders to ensure seamless planning, execution, and closure of clinical trials.
- Navigate a complex regulatory environment while managing global clinical trials with multidisciplinary teams.
- Represent the organization in meetings with regulatory agencies and investigational sites, ensuring adherence to project deliverables.
- Oversee the preparation, conduct, and closeout phases of clinical trials, serving as the primary contact for site staff and investigators.
Essential Skills:
- Exceptional communication skills, capable of navigating complex cross-functional environments.
- Strong project management and stakeholder engagement abilities, with a solid understanding of clinical development processes.
- Technical expertise in clinical trial operations, with knowledge in relevant therapeutic areas being advantageous.
- Proven leadership skills, with the ability to resolve conflicts and influence at various organizational levels.
- Strategic mindset with a focus on risk identification and mitigation planning.
- Proficient in setting priorities and managing resources effectively.
- Willingness to travel domestically as required.
Qualifications:
A Bachelor's degree with a minimum of 6 years of experience in clinical research, preferably within the pharmaceutical sector; or a Master's degree or PharmD with at least 4 years of relevant experience; or a PhD or MD with a minimum of 2 years in clinical research.
Core Competencies:
Clinical Trial Monitoring, Clinical Operations, Good Clinical Practice (GCP)
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