Clinical Operations Manager - Finance

Msd; São Paulo; Presencial; BRL 80.000 - 120.000; Tempo integral

Resumo da oferta

A healthcare company in São Paulo is seeking a professional to manage clinical trial budgets and ensure compliance with regulatory standards. The role involves negotiating agreements, overseeing financial aspects, and coordinating with various teams to achieve project goals. Candidates should have expertise in clinical systems and strong communication skills in both local language and English. This position requires problem-solving abilities and the capacity to lead teams effectively.

Qualificações

• Ability to indirectly influence investigators and vendors.
• Strong knowledge of budget and contract negotiations.
• Ability to lead a team of CTCs.

Responsabilidades

• Manage country and site budgets.
• Negotiate and complete Clinical Trial Research Agreements.
• Oversee financial forecasting and compliance.
• Coordinate local processes and filing requirements.

Conhecimentos

Expertise of core clinical systems, tools and metrics

Excellent verbal and written influencing skills

Strong coordination and organizational skills

Knowledge of budget and contract negotiations

Problem solving

Descrição da oferta de emprego

Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation.

Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine.

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 Head COMs, the person is responsible for budget / finance aspects, for execution and oversight of clinical trial contracts to ensure Site Ready.

Responsibilities

• 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 Sr.COM / other roles.
• 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.
• Provide support and oversight to local vendors as applicable.
• Oversees and coordinates local processes, 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 financial compliance.
• Required to in / directly influence investigators, external partners and country operations and adheres to budget targets and agreed payment timelines.
• Contributes strongly to COM team and other Country Operations roles knowledge by acting as 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.

Core competencies

• Expertise of core clinical systems, tools and metrics
• Excellent verbal and written influrencing and training / mentoring skills, in local language and English
• Strong coordination and organizational skills
• Strong knowledge of budget and contract negotiations and understanding of how these impact study start-up, desired knowledge of local regulatory environment and submission and approval processes,
• 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.
• 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.
• 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, 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 simultane