Director - Clinical Operations

PURPOSE OF THE ROLE:

The Director, Clinical Operations (COD) has overall responsibility for customers management and operational excellence of the Clinical Operations department. This includes the provision of overall clinical leadership, as well as the supervision of Clinical Operations activities to ensure service levels and quality meet and exceed established clinical standards. In this context, the COD engages in the creation, innovation, evaluation, development and implementation of structures and process improvement initiatives and collaborates and facilitates communication and translation of business, regulatory and technology requirements regarding all clinical facets among departments.

Responsibilities:

Strategy and Planning:

• Collaborate with the COO to define long-term strategic plans for the Clinical Operations department, ensuring alignment with business objectives.
• Participate in various bid defense meetings and provide inputs to various proposals inline with the project constraints.
• Review potential impacts of project specifications and targets on budget and operational performance, proactively addressing any risks.
• Develop the operational strategy and provide guidance to downstream team for aligning it with the overall business strategy, focusing on growth, profitability, and customer satisfaction within own department.
• Monitor market trends, competitive landscape, industry developments, and technological advancements to identify opportunities for business growth and expansion.

Operational Management:

• Provide strategic leadership and oversight for the Clinical Operations reporting line, including Clinical Supplies, Vendor Management, Start-Up Management, Contracts Management, Training Management, and the core Clinical Operations team (e.g., CRAs, CTAs).
• Oversee daily departmental operations, guiding teams to drive operational excellence and meet organizational goals.
• Evaluate and optimize operational processes using approaches such as Lean, Six Sigma, and innovative digital solutions to improve efficiency and effectiveness.
• Review audit findings and recurring operational issues, implementing effective solutions and corrective actions to strengthen quality and compliance.
• Collaborate with cross-functional leaders to understand priorities and challenges, strengthen relationships, and ensure aligned actions across teams.

Project Management

• Review department operational performance metrics, reports and highlight any significant deviations to COO to meet project profitability targets.
• Guide downstream team on preparation and implementation (if needed) of contingency plans.
• Collaborate across other departments to ensure alignment on project goals and deliverables, facilitating effective communication and teamwork.

Client Management:

• Manage high level strategic customer accounts and act as the escalated point of contact for clients regarding clinical operations, ensuring clear communication and understanding of project status and expectations.
• Participate in client presentations and represent clinical operations in external initiatives as assigned by management, showcasing the department's capabilities and successes.
• Review client feedback and guide downstream team to inform process improvements and enhance service delivery.

Quality Assurance:

• Participate in Quality Review Management and continuous improvement initiatives, ensuring alignment with company, client, and department objectives.
• Review the impact of quality assurance programs, process changes etc. for achieving desired results/improvements and guide own team to adjust processes as necessary.
• Coach own team, conceptualize multiple initiatives to achieve overall reduction in customer complaints.

Policies, Processes & Procedures:

• Create standardized policies, processes, procedures within own department in line with applicable regulatory/ legislative requirements while delivering high quality and cost-effective results.
• Promote a culture of innovation and continuous improvement through adapting to changes in standards, changes in the business environment and adoption of leading practices within department.
• Oversee compliance with company policies, procedures, Standard Operating Procedures (SOPs), Quality and Information Security Management Systems, ICH GCPs, and client contractual expectations.

People Management:

• Promote the organization's culture across own team to ensure its alignment with the required and desired behaviors.
• Instill a culture of continuous development and performance within the department.
• Lead by example by encouraging teamwork, driving results and excellence, developing, and grooming talent and demonstrating role modelling behavior.
• Proactively participate in recruiting, development & engagement of own team and other key departmental roles, if needed.
• Set and communicate clear performance expectations and guidelines, coach, and provide support and regular feedback to own team and overall department.
• Evaluate training and development requirements for department level capability building and make recommendations for learning interventions.