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Clinical Operations Manager

4 semanas atrás

São Paulo, São Paulo, Brasil MSD Tempo inteiro
This role is accountable for performance and compliance for assigned protocols in a country in compliance and regulations, policies and procedures, quality standards and adverse event reporting requirements internally and externally.
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**:
- Ownership of country and site budgets. Development, negotiation and completion of Clinical Trial Research Agreements.
- 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 Senior Clinical Operations Manager.
- 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 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 Clinical Research Team, (Finance and Legal if appropriate) to ensure country deliverables are obtained for submissions, budgets, Clinical Trial Research Agreements and local milestones. Collaborates closely with Regional Operations 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.
**Qualifications**
- Solid experience in Clinical Research and Logistic Processes (Import/Export and Supply Mgmt)
- Fluent English
- Requires expertise of core clinical systems, tools and metrics
- Strong coordination and organizational skills required
- Requires 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 to address and resolve issues.
- Ability to make decisions independently. Able to manage important activities relevant to clinical research activities in the country according to predetermined global policies and commitments. Requires strong understanding of local regulatory environment for the individual to weigh pros and cons of key decisions with input from manager.
- Extensive experience in clinical research operations and experience with project management and coordination.
- Expertise of core clinical, regulatory and financial systems, tools, metrics and local requirements is essential.
- Ability to proactively develop risk management and mitigation plans in the country and resolve issues locally.
- Problem solving is essential to this position. Requires the ability to pro-actively identify issues and risks, analyze root cause, and propose solutions to problems and escalate to management as applicable.
- 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.
We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we "follow the science" that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
LI-DNI
**Search Firm Representatives Please Read Carefully**
**Employee Status**:
Regular
**Relocation**:
No relocation
**VISA Sponsorship**:
No
**Travel Requirements**:
No Travel Required
**Flexible Work Arrangements**:
Hybrid
**Shift**:
1st - Day
*