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Senior Director of Clinical Operations

1 month ago

Atlanta, United States augmentjobs Full time
Job DescriptionJob DescriptionJob Title: Senior Director of Clinical Operations

Salary Range: $180,000 to $220,000
Experience Level: 8 to 12 years
Company Name: Augmentjobs

Job Description:

The Senior Director of Clinical Operations at Augmentjobs is a pivotal leadership role responsible for overseeing and directing all clinical operations activities. This includes ensuring the effective planning, execution, and management of clinical trials and programs in compliance with regulatory standards and company objectives. The ideal candidate will have extensive experience in clinical operations, a strategic mindset, and a proven track record of leading high-performing teams.

Key Responsibilities:

  • Strategic Leadership: Develop and implement strategic plans for clinical operations, ensuring alignment with company goals and regulatory requirements.

  • Clinical Trial Management: Oversee the planning, initiation, execution, and completion of clinical trials, ensuring adherence to timelines, budgets, and quality standards.

  • Team Leadership: Lead, mentor, and develop a team of clinical operations professionals, fostering a culture of excellence and continuous improvement.

  • Regulatory Compliance: Ensure all clinical activities comply with regulatory requirements (e.g., FDA, EMA) and Good Clinical Practice (GCP) guidelines.

  • Stakeholder Collaboration: Collaborate with internal and external stakeholders, including regulatory bodies, research organizations, and key opinion leaders, to drive clinical programs forward.

  • Budget Management: Develop and manage clinical operations budgets, ensuring cost-effective use of resources.

  • Risk Management: Identify potential risks in clinical operations and develop mitigation strategies to address them.

  • Performance Monitoring: Establish and monitor key performance indicators (KPIs) to track the progress and success of clinical programs.

  • Quality Assurance: Implement and maintain quality assurance processes to ensure the highest standards of clinical data integrity and patient safety.

  • Innovation: Drive innovation in clinical operations processes, leveraging new technologies and methodologies to enhance efficiency and effectiveness.

Required Skills and Qualifications:

  • Education: Advanced degree in life sciences, clinical research, or a related field (e.g., MD, PhD, MSc).

  • Experience: 8 to 12 years of experience in clinical operations, with at least 5 years in a leadership role.

  • Leadership Skills: Proven ability to lead and inspire high-performing teams, with strong interpersonal and communication skills.

  • Clinical Expertise: Deep understanding of clinical trial processes, regulatory requirements, and GCP guidelines.

  • Strategic Thinking: Strong strategic and analytical skills, with the ability to develop and implement effective clinical operations strategies.

  • Project Management: Excellent project management skills, with the ability to manage multiple complex projects simultaneously.

  • Problem-Solving: Strong problem-solving skills, with the ability to identify and address issues proactively.

  • Budget Management: Experience in developing and managing clinical operations budgets.

  • Collaboration: Demonstrated ability to work effectively with cross-functional teams and external partners.

  • Innovation: A track record of driving innovation and continuous improvement in clinical operations.

Preferred Skills:

  • Global Experience: Experience managing clinical trials on a global scale.

  • Technology Savvy: Familiarity with clinical trial management systems (CTMS) and other relevant technologies.

  • Regulatory Knowledge: In-depth knowledge of regulatory requirements in multiple regions (e.g., North America, Europe, Asia).

  • Networking: Established network within the clinical research and pharmaceutical industry.

Join Augmentjobs as a Senior Director of Clinical Operations and play a critical role in advancing our clinical programs and driving innovation in clinical research. If you are a strategic leader with a passion for clinical excellence, we encourage you to apply.