Clinical Operation Manager com

hace 2 semanas

Bogota, Colombia MSD A tiempo completo

**Job Description**:
This role is accountable for performance and compliance for assigned protocols in a country in

compliance with ICH/GCP and country regulations, Merck/MSD policies and procedures, quality

standards and adverse event reporting requirements internally and externally.

Under the oversight of the Sr. COM, Head COMs or CRD, for execution and oversight of clinical trial country submissions and approvals and to ensure Site Ready.

Responsibilities include, but are not limited to:

- Ownership of country and site budgets. Development, negotiation and completion of Clinical Trial Research Agreements (CTRA).
- 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.
- Contributes to the development of local SOPs. Oversees CTCs as applicable.
- 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. Enters and updates

country information in clinical and finance systems.
- Ownership of local regulatory and financial compliance. The position has a significant impact on

how a country can deliver country-specific trial commitments and objectives especially during

study start-up.
- Required to in/directly influence investigators, external partners and country operations and

adheres to budget targets and agreed payment timelines.
- Works in partnership internally with GCTO country operations, finance, regulatory affairs,

pharmacovigilance, legal and regional operations, HQ functional areas and externally with

vendors and sites, IRB/IECs and Regulatory Authorities in submission and approval relatedinteractions. Through continual interaction with local clinical team/s successfully delivers clinical

and financial contracts within fair market value.
- 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

**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**:R234415

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