Clinical Operations Manager

3 giorni fa

Roma, Italia MSD A tempo pieno

This role is accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, our Company policies and procedures, quality standards and adverse event reporting requirements internally and externally.

Under the oversight of the COM Lead, the person is responsible for

budget/finance aspects, for execution and oversight of clinical trial country submissions and approvals and to ensure Site Ready.

**Responsibilities include, but are not limited to**:

- Executes and oversees clinical trial country submissions and approvals for assigned protocols;
- Develops local language materials including local language Informed Consents and Translations;
- Interacts with IRB/IEC and Regulatory Authority for assigned protocols;
- Manages country deliverables, timelines and results for assigned protocols to meet country
- commitments. Responsible for quality and compliance in assigned protocols in country;
- Coordinates and liaises with CRM, CTC, CRA, (Finance and Legal if appropriate) to ensure
- country deliverables are obtained for submissions, budgets, CTRAs and local milestones;
- Collaborates closely with Headquarter to align country timelines for assigned protocols;
- Provide support and oversight to local vendors as applicable;
- Oversees and coordinates local processes, clinical and ancillary supplies management, importing and exporting requirements, supplies destruction, local electronic/hard copy filing, archiving and retention requirements, and insurance process management. E
- Enters and updates country information in clinical and finance systems;
- Contribute or lead initiatives and projects adding value to the business, as appropriate/required;
- Contributes strongly to COM team and other Country Operations roles knowledge by acting as process Subject Matter Expert (SME), sharing best practices, making recommendations for continuous improvement and providing training as appropriate/required.
- Contributes to COM team knowledge by acting as buddy/mentor and sharing best practices as appropriate/required.

**Education and Minimum Requirements**:

- Bachelor’s or advanced degree in science and/or with relevant work experience in direct site management (monitoring) in bio/pharma/CRO.

**Required Experience and Skills**:

- Bachelor's Degree in Business Finance/ Administration/ Life Science;
- Expertise of core clinical systems, tools and metrics;
- Excellent verbal and written influencing and training/mentoring skills, in local language and English;
- Strong coordination and organizational skills;
- Skilled knowledge of budget and contract negotiations, local regulatory environment and submission and approval processes, and understanding of how these impact study start-up;
- Ability to indirectly influence investigators, vendors, external partners and country managers to address and resolve issues, with mínimal support from the Sr.COM or manager. Ability to make decisions independently with limited oversight from Sr.COM or manager.
- Requires strong understanding of local regulatory environment
- Ability to proactively develop risk management and mitigation plans in the country and resolve issues locally.
- Ability to lead a team of CTCs as applicable

**Search Firm Representatives Please Read Carefully**

**Employee Status**:
Regular

**Relocation**:
**VISA Sponsorship**:
**Travel Requirements**:
**Flexible Work Arrangements**:
Hybrid

**Shift**:
**Valid Driving License**:
**Hazardous Material(s)**:
**Job Posting End Date**:
12/7/2024

**Requisition ID**:R324267

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