Director of Clinical Operations

Director of Clinical Operations will provide leadership, project management, and oversight to plan and conduct clinical trials concurrently in accordance with the Sponsor, all regulatory organizations, Standard Operating Procedures (SOPs), Good Clinical Practices (GCP), and regulatory guidelines across all DMCR site and guidance for the day-to-day and long-term goals across DMCR sites.

DUTIES & RESPONSIBILITIES

• Provides leadership and guidance for the day-to-day and long-term goals across DMCR sites
• Identify potential areas of risk, set priorities for internal reviews, site monitoring (of investigative sites and administrative departments) and review, and approve corrective actions needed, inclusive of mitigation strategies
• Coordinate with study teams to identify strategies for improved subject outcomes, site operating efficiencies, optimum subject experience and risk assessment action plans for short-term and long-term planning
• Identifying areas for improvement and developing detailed process flows, policies, and procedures to ensure consistent quality data is being collected across DM Clinical Research sites.
• With senior leadership including Sponsor, Site Directors, and Clinical Operations staff, managing all clinical and operational aspects of each trial, allocating resources as needed.
• Direct, develop and implement programs to promote the recruitment, retention and growth of operational staff. Inclusive of individual professional growth.
• Manages clinical operational performance across DMCR sites
• Manages relationships with internal and external stakeholders, such as sponsors and DMCR verticals
• Directing and managing clinical operations personnel, including hiring, performance reviews, and termination.
• Monitoring and reporting protocol performance, timelines, and financial metrics on an ongoing basis to the management team, including current status of protocol.
• Collaboration with cross functional teams to achieve maximum productivity, client satisfaction and achieve KPIs
• Foster a culture in-line with DMCR core values to ensure a productive and inclusive environment
  • Agility, Efficiency, Ethics, Excellence, Growth, Humility, Integrity, Leadership, Partnership, People,
• Quality and Safety
• Executive level reporting and presentations
• Any other matters as assigned by management.

KNOWLEDGE & EXPERIENCE

Education:

• Bachelors Degree, in a field of Medicine, Science, Behavioral Science, Nursing or related field, required
• Masters degree or higher, preferred

Experience:

• 8 years experience in a clinical research environment
• 5 years in leading large teams including progressive responsibilities
• 3 years in process improvement and high-level planning
• 3 years in managing internal and external relationships

Credentials:

• DMCR-required training, including GCP and IATA
• ACRP or CCRP or ability to attain within 12 months of appointment

Knowledge and Skills:

• Current FDA regulations, GCP/ICH guidelines, organizational SOPs, guidance documents and study protocols
• Strong skills with MS Office and/or Google Suite products
• Strong leadership and development skills
• Strong communication skills, both written and verbal
• Strong organization and presentation skills
• Strong time skills in decision-making and resource management
• Strong skills in planning and implementation