Associate Clinical Operations Manager I
6 months ago
This role is accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, policies and procedures, quality, standards and adverse event reporting requirements internally and externally.
Under the oversight of the Sr.COM/COM Lead, the person is responsible for execution and oversight of clinical trial country submissions and approvals.
**Responsibilities** include, but are not limited to:
- Contribute to Execution and oversight clinical trial country submissions and approvals for assigned protocols.
- Develops local language materials including local language Informed Consents and translations.
- Interact 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, other functions areas to ensure country
deliverables are obtained for submissions, budgets, CTRAs and local milestones.
- Support of local regulatory and financial compliance. Ability 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 related
- interactions. Through continual interaction with local clinical team/s successfully delivers clinical and financial contracts within fair market value.
- 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 systems.
- Provide support and oversight to local vendors as applicable.
- Contributes to the development of local SOPs.
- 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/supporting 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 sharing best practices appropriate/required.
- May act as buddy / mentor.
**Qualification & Experience**:
- 2-5 years of experience in Clinical Research
- Preferred: Bachelor’s degree
**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)**:
**Requisition ID**:R289935
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