Associate Clinical Operations Manager 1
4 weeks ago
**Brief Description of Position**:
This role is accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, our Company's policies and procedures, quality standards and adverse event reporting requirements internally and externally. Under the oversight of the Sr. COM, Head COMs or CRD, the person is responsible for Supporting budget/finance aspects, for execution and oversight of clinical trial country submissions and approvals.
**Responsibilities include but are not limited to**:
- Support to country and site budgets. Development, negotiation and completion of Clinical Trial Research Agreements (CTRA).
- Oversees and tracks clinical research-related payments. Payment reconciliation at study close
- out. Oversees FCPA, DPS/OFAC, and maintenance of financial systems. Support of Financial forecasting in conjunction with Sr.COM /other roles.
- Contribute to Execution and oversight of clinical trial country submissions and approvals for assigned protocols.
- Develops working knowledge of local language materials including local language Informed Consents and translations. May interact with IRB/IEC and Regulatory Authority for assigned protocols.
- Supports 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.
- 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.
- Provide support to local vendors as applicable.
- Support local processes, clinical and ancillary supplies management, importing and exporting requirements, supplies destruction, local electronic/hard copy filing, archiving and retention requirements. Enters and updates country information in clinical and finance systems.
- Support of local regulatory and financial compliance.
- Acquire knowledge how 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 with support of an experienced COM. Through continual interaction with local clinical team/s successfully delivers clinical and financial contracts within fair market value.
- Contribute to initiatives and projects adding value to the business, as appropriate/required.
- Contributes 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 as appropriate/required.
- Contributes to COM team knowledge by sharing best practices as appropriate/required.
**Qualifications & Experience**:
- 1-2 years of experience in Clinical Research or experience in Finance/Business
- ** Required**:Associate degree or equivalent Health Care related experience
- ** Preferred**: Bachelor’s degree
**Skills Required**:
- Excellent verbal and written skills, in local language and English.
- Strong coordination and organizational skills.
- Basic knowledge of budget and contract negotiation process, local regulatory environment and submission and approval processes, and understanding of how these impact study start-ups.
- Ability to propose solutions to local study teams.
- ICH/GCP knowledge appropriate to role. Hands on knowledge of Good Documentation Practices.
- Able to work with other experienced clinical research professionals to learn and develop skills to manage protocols independently. Works with high quality and compliance mindset.
- Effective and efficient time management, organizational and interpersonal skills, conflict management and problem-solving skills.
- High sense of accountability and urgency in order to properly prioritize deliverables.
- Strong communication and negotiation skills in local language and English.
- Ability to focus on multiple deliverables and protocols simultaneously is essential. Requires that the individual has ability to work effectively also in a remote virtual environment with a wide range of people.
- Positive & growth mindset, capable of working independently and being self-driven.
**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**:R266925
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