Clinical Operations Manager

5 months ago

Midrand, South Africa MSD Full time

This role is accountable for performance and compliance for assigned protocols in South Africa and Other African Countries 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 COM lead, Head COMs or CRD, you are responsible for budget/finance aspects, for execution and oversight of clinical trial country submissions and approvals and to ensure Site Readiness.

**Primary 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 closeout. Oversees FCPA, DPS/OFAC, and maintenance of financial systems. Financial forecasting in conjunction with COM Lead /other roles.
- 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 Headquarters to align country timelines for assigned protocols.
- 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 related interactions. Through continual interaction with local clinical team/s successfully delivers clinical and financial contracts within fair market value.
- Contributes strongly to COM team and other Country Operations roles knowledge by acting as Finance 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

**Other responsibilities may include**:

- 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.
- Provide support and oversight to local vendors as applicable
- Manages country deliverables, timelines and results for assigned protocols to meet country commitments. Responsible for quality and compliance in assigned protocols in country.
- Contribute or lead initiatives and projects adding value to the business, as appropriate/required.

**Qualifications, Skills & Experience**

Core competencies:

- Expertise of core clinical systems, tools and metrics
- Excellent verbal and written influencing and training/mentoring skills, in local language and English
- 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 Sr.COM or manager.
- Ability to make decisions independently with limited oversight from Sr.COM 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.
- Ability to lead a team of CTCs as applicable

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.
- 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
-

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