Director, Clinical Management

**Job Title**: Director, Clinical Management
- (Homebased)

**Job Location**: Italy

**Job Overview**:
Supervises and is responsible for the growth and development of a group of Clinical Trial Managers (CTMs). Assumes a leadership role in the oversight of the clinical part of one or more client-sponsored programs, ensuring quality and integrity of data, compliance with the Company’s or Sponsor SOPs, ICH-GCP, and regulatory requirements, delivering study completion on time and within budget; Supports business development activities; responsible for the integration of company operational processes across clinical management and the management of operational metrics.

**Job Duties and Responsibilities**:

- Provides guidance and oversight to the clinical management team (CTMs) to ensure adherence to project scope, SOPs, timelines, and budget requirements.
- Identification of regional clinical management resources, and ongoing management of project allocation & utilization
- Responsible for compliance - ensuring CTMs achieve role-specific KPIs and meet project deliverables
- Review of non-billable time and expenses
- Supports recruitment through the conduct of initial screening, phone, and face-to-face interviews of potential CTMs.
- Responsible for the onboarding and training of new CTM hires
- Involvement in regional training, quality initiatives, and review of metrics to ensure consistent service delivery.
- Responsible for the ongoing training & development of CTMs
- Conducts annual appraisals and other ongoing QC assessments. Develops and communicates corrective action plans for employees identified with performance issues.
- Assures compliance to corporate Standard Operating Procedures (SOPs), ICH GCP, and other regulatory requirements through active performance management, quality control checks, and project metrics analysis.
- Contributes to the development, revision, and improvement of current work processes with global counterparts
- Contributes to company-level initiatives and cross-functional initiatives as they relate to clinical management and ensures department needs are represented.
- Attends and contributes in departmental, regional, and company meetings as required
- Leads regular CTM meetings ensuring updates, expectations, best practices, and training is shared within the global CTM team
- Liaises with cross-functional counterparts as part of project oversight and in ensuring that other functions are kept informed of clinical management updates and have the opportunity to participate in initiatives where necessary
- 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**:
Direct line management of Associate Directors, and CTMs and provision of work direction and guidance. 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 10 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 2 years), or an equivalent combination of education & experience to successfully perform the key responsibilities of the role
- Extensive experience in clinical research
- Skills/Competencies
- Experience working in a team environment under time and resource pressures
- Strong leadership and management skills
- Demonstrated ability to manage workload, staff allocation, quality, and project budgets
- Understanding of the principles of project management, including finances
- Excellent communication skills, written and verbal
- Good English language skills
- Team player - effective participant as a team member and team leader
- Creative, change agent - a leader in pursuing positive improvements
- Practices professionalism and integrity in all actions
- Capabilities
- Ability to work remotely
- Demonstrated ability to negotiate effectively, resolve conflicts and build consensus
- Ability to travel as required

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