Clinical Operations Manager - Sao Paulo, Brasil - MSD

MSD
MSD
Empresa verificada
Sao Paulo, Brasil

há 1 mês

Ana Silva

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Ana Silva

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Descrição

Job Description:

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 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 researchrelated 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. The position has a significant impact on how a country can deliver countryspecific trial commitments and objectives especially during study startup.
  • 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 relatedinteractions. Through continual interaction with local clinical team/s successfully delivers clinical
and financial contracts within fair market value.

Contribute or lead initiatives and projects adding value to the business, as appropriate/required.

  • 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 startup, 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. Requires the ability to proactively 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 problemsolving 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 a
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