Clinical Operations Manager

hace 3 días

Munro, Argentina MSD A tiempo completo

Join us in our mission to INVENT the future. Let’s be part of our team of dedicated, energetic individuals who are committed to be the most trusted supplier of pharmaceuticals and health products worldwide.

**Key Responsibilities**

PERFORMANCE & COMPLIANCE
- Accountable for execution and oversight of local operational clinical trial activities in a country for assigned protocols in compliance with international and country regulations, company policies and procedures, quality standards and adverse event reporting requirements internally and externally.

COUNTRY SUBMISSIONS & LOCAL LANGUAGE MATERIALS
- Responsible for execution and oversight of clinical trial country submissions and approvals for assigned protocols. Development of local language materials including local language Informed Consents and translations.

MANAGEMENT & QUALITY OVERSIGHT
- Responsible for managing country deliverables, timelines and results for assigned protocols to meet country commitments. Responsible for quality and compliance in assigned protocols in country. Contributes to the development of local SOPs.

COLLABORATION
- Coordinates and liaises with CRM, CTC, CRA, to ensure country deliverables are obtained for submissions and local milestones. Collaborates closely with Regional Operations to align country timelines for assigned protocols. Provides support and oversight to local vendors as applicable.

LOCAL PROCESS OVERSIGHT
- Oversight and coordination of local regulatory processes. Responsible for HA and EC submissions and approvals. Start-Up and On-Going responsibilities. Enters and updates country information in clinical and finance systems.

**Experience Requirements**:

- 5 years of experience in clinical research.
- Bachelor's Degree in Business Finance/ Administration/ Life Science or equivalent Health Care related experience

**Search Firm Representatives Please Read Carefully**

**Employee Status**:
Regular

**Relocation**:
No relocation

**VISA Sponsorship**:
No

**Travel Requirements**:
No Travel Required

**Flexible Work Arrangements**:
Hybrid

**Shift**:
Not Indicated

**Valid Driving License**:
No

**Hazardous Material(s)**:
no
**Requisition ID**:R291185

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