Head Of Clinical Operations Lazio

Head Of Clinical Operations
Roma
Lazio, Lazio

We are excited to announce a fantastic opportunity for an experienced professional to join our team as the Head of Clinical Operations.

In this critical leadership role, you will be accountable for the overall execution and oversight of local operational clinical trial activities, ensuring strict adherence to ICH/GCP guidelines, country regulations, and our company's policies and procedures.

Your responsibilities will include ownership, oversight, and impact on local regulatory and financial compliance, as well as strategic out-tasking as applicable.

- The core responsibility of this role is to manage and lead the strategy and execution of all regulatory, financial and logistics activities associated with insourced clinical studies.

- The role will manage Sr. COMs, Clinical Operation Managers (COM) and Clinical Trial Coordinators (CTC) within the countries/clusters, based on specific country requirements

Primary responsibilities for the role includes:

- Manages direct reports including performance plans and development plans.

Oversee the performance management and career development of staff and effectively manage performance issues

- Work closely with country CRDs, HSMM/CRA-Manager and TA-Heads to assess program strategy and alignment of project deliverables and objectives

- Partners with Headquarters based colleagues to help drive company strategy, with specific focus on standards of practice for site budgeting, site contracting, Informed Consents, and management of Central IRBs and applicable Health Authorities.

Create, promote, and direct a strategy for rapid start up activities

- Establish country procedures and processes for all relevant activities (managing site contracts and budget negotiation and escalation, regulatory submissions and approvals; procedures and processes for managing logistics and purchasing of drugs and materials for study start up.

)

- Responsible to ensure all projects are adequately resourced and tracked to ensure optimal efficiency and attainment of goals, milestones, and targets while ensuring high quality standards are maintained

- Establishing a strategy for partnering and monitoring all vendors/service providers that support operational implementation and management of Sr. COM, COM and CTC responsibilities.

(Includes manpower providers, Central IRB vendors, etc.

)

Qualifications, Skills & Experience:

- Education B. S.

degree.

Preference of Master of Science or Medicine (or comparable)

- 10-12 years of relevant clinical research or operational experience.

- Familiar with ICH/GCP principles and all related national regulations

- Working with multiple external partners with adequate controls, governance, and oversight

- Leadership and people management

- Knowledge and experience managing personnel and processes in a matrix managed organization

- Knowledge and experience in all clinical trial startup and ongoing management activities and processes

- Knowledge and awareness of clinical trial operations from a clinical research site perspective

**Search Firm Representatives Please Read Carefully

**Employee Status**:

Regular

**Relocation**:

**VISA Sponsorship**:

**Travel Requirements**:

**Flexible Work Arrangements**:

**Shift**:

**Valid Driving License**:

**Hazardous Material(s)**:

**Requisition ID**:R277171