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Director of Clinical Operations
1 month ago
Augmentjobs is seeking a highly experienced and strategic Director of Clinical Operations to oversee and manage the clinical operations team. The ideal candidate will have a proven track record of leading clinical projects and ensuring the highest quality of clinical trials and studies. This role demands strong leadership, extensive clinical knowledge, and the ability to work collaboratively with cross-functional teams.
Key Responsibilities:Leadership and Management:
Lead, mentor, and develop the clinical operations team, fostering a culture of excellence and continuous improvement.
Ensure effective allocation and utilization of resources to meet project timelines and objectives.
Develop and implement strategies to enhance the efficiency and effectiveness of clinical operations.
Project Oversight:
Oversee the planning, execution, and completion of clinical trials and studies, ensuring compliance with regulatory requirements and company standards.
Monitor project progress, budgets, and timelines, and address any issues or deviations promptly.
Collaborate with cross-functional teams, including regulatory affairs, quality assurance, and data management, to ensure the successful execution of clinical projects.
Regulatory Compliance and Quality Assurance:
Ensure all clinical activities comply with applicable regulations, guidelines, and ethical standards.
Oversee the development and implementation of standard operating procedures (SOPs) and ensure adherence to these standards.
Lead audits and inspections, addressing any findings and implementing corrective actions as necessary.
Stakeholder Management:
Build and maintain strong relationships with key stakeholders, including investigators, study sites, vendors, and regulatory authorities.
Represent the company in meetings with regulatory bodies and other external stakeholders.
Provide regular updates and reports to senior management on the status of clinical projects and operations.
Budget and Resource Management:
Develop and manage budgets for clinical operations, ensuring efficient use of resources and adherence to financial targets.
Negotiate contracts and agreements with vendors, ensuring favorable terms and conditions.
Education:
Bachelor's degree in a related field (e.g., life sciences, nursing, pharmacy). Advanced degree (e.g., MS, MPH, PhD) preferred.
Experience:
7 to 10 years of experience in clinical operations, with at least 3 years in a leadership or management role.
Proven experience in overseeing clinical trials and studies, from initiation to completion.
Strong knowledge of GCP, ICH guidelines, and regulatory requirements.
Skills:
Exceptional leadership and team management skills.
Excellent organizational and project management abilities.
Strong analytical and problem-solving skills.
Outstanding communication and interpersonal skills.
Ability to work effectively in a fast-paced, dynamic environment.
Proficiency with clinical trial management systems (CTMS) and other relevant software.
The Director of Clinical Operations will report to the Vice President of Clinical Development.
This role may require occasional travel to study sites and industry conferences.
Join Augmentjobs and be a part of a dynamic team committed to advancing clinical research and improving patient outcomes. Apply today to take your career to the next level