Associate Director, Clinical Management

Job Description:

Job Title: Associate Director, Clinical Management

Job Location: Homebased (United States)

Job Overview:

Responsible for strategic leadership and growth of regional clinical management as an integral part of Clinical Operations. The Associate Director is responsible for the delivery of quality clinical operations services, the growth and development of assigned direct reports, and the support of business development activities. The Associate Director is responsible for the global integration of the Company’s clinical operations processes across the organization and the management of operational metrics.

Job Duties and Responsibilities:

• Provides guidance and oversight to the regional clinical management team to ensure adherence to project scope, SOPs, timelines, and budget requirements.
• Responsible for the appropriate identification of regional clinical management resources manages Clinical Trial Manager (CTM) utilization and metrics
• Responsible for ensuring CTMs achieve target benchmark for trip report compliance, monitoring back-log and utilization
• Review of non-billable time and expenses
• Provide support for the remote monitoring program
• Supports CTM hiring initiative through the conduct of initial screening, phone, and face-to-face interviews of potential -new employees.
• Responsible for contributing to the CTM new hire training materials and onboarding of new CTMs
• Supports project management with collaborative field team structuring, ensuring the most appropriate, effective, and efficient assignment of clinical management resources per project needs, budgets, and timelines.
• Supports regional training, quality initiatives, and metrics to ensure consistent service delivery.
• Responsible for the departmental training growth and development of CTM. May work with project teams to provide project-specific mentoring.
• Provides CTMs with feedback following performance evaluation assessments and annual reviews. Develops and communicates corrective action plans for employees identified with performance issues.
• Assure compliance to corporate Standard Operating Procedures (SOPs), ICH/GCPs, and other regulatory requirements through active performance management, quality control checks, and project metrics analysis.
• Develop/identify or revise current work processes with global counterparts, procedures, and tools and works collaboratively with other department leaders to assure process hand-offs and efficiencies.
• Provides leadership and contributes to company-level initiatives as they relate to clinical management and ensures department needs are represented.
• Leads or participates in regular CTM meetings ensuring updates, expectations, best practices, and training is shared within the global CTM team
• Supports business development and sales, including review of RFPs/budgets & proposals, identification of staff to assign to BDMs & proposals, support of staff attending BDMs, and participation at conferences, tradeshows, and BDMs as required
  
  

Supervisory Responsibilities:

Provides work direction and oversight to CTMs. Carries out supervisory responsibilities in accordance with the organization’s policies. Responsibilities include interviewing, hiring, training, planning, assigning and directing work, and performance management.

Job Requirements:

• Education
• BA/BS and advanced degree preferred or relevant experience. Health/science preferred.
• Experience
• Minimum 7 years of CRO/Sponsor experience in healthcare product development and at least 2 years experience in CRO management.
• Previous experience within clinical monitoring and/or clinical management preferred
• Line management experience (minimum of 1 year), or an equivalent combination of education & experience to successfully perform the key responsibilities of the role
• Extensive experience in clinical research
• Skills/Competencies
• Knowledge of field organizational strategies. The ability to adapt to a rapidly changing work environment.
• Demonstrates ability to make decisions critical to staffing, quality, and resources allocation.
• Experience managing a large number of direct and indirect reports and/or experience managing large teams.
• Demonstrated experience leading and facilitating.
• Successful management skills
• Positive leadership
• Ability to speak to a group of people in a training environment.
• Ability to deliver feedback effectively.
• Practices professionalism and integrity in all actions
• Develop, mentor, and lead people and teams
• Creative, change agent – a leader in pursuing positive improvements
• Team player – effective participant as a team member and team leader
• Capabilities
• Ability to work remotely
  

Ability to travel as required

The company will not accept unsolicited resumes from third party vendors.