Clinical Operations Manager
2 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 SCOM, 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:
- Ownership of 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. Financial forecasting in conjunction with SCOM /other roles.
- 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.
- Provides 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 to adhere to partners and country operations to adhere 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.
**Reports to**:
- Senior Clinical Operations Manager
**Location**:
- South Africa - Office Based
**Extent of Travel**:
- Minimal travel required
**Qualifications, Skills & Experience**
**Core competencies**:
- Expertise of core clinical systems, tools and metrics
- Excellent English skills
- 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 SCOM or manager.
- Ability to make decisions independently with limited oversight from SCOM 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.
**Behavioural Competency Expectations**:
- Problem solving is essential to this position.
Requires the ability to pro-actively identify issues and risks, analyse root cause, and propose solutions to problems and escalate to management as applicable.
Specific examples of common problems include:
1) Issues in budget / CTRA negotiations,
2) Quality and compliance issues,
3) Regulatory and legal issues, and
4) issues related to functional area deliverables that could jeopardize protocol milestones.
- Strong communication, leadership, and negotiation skills as well as excellent influencing and training/mentoring skills, both written and verbal, 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.
**Experience Requirements**:
**Required**:
- 5 years of experience in clinical research or combined experience in Clinical Research and Finance/Business
**Educational Requirements**:
Required:
- Bachelor's Degree in Busi
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