Clinical Research Manager

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

Resumo da oferta

A leading biopharmaceutical company is seeking a Clinical Research Manager in São Paulo, Brazil. The candidate will be accountable for project management of clinical trials, ensuring compliance with regulations and quality standards. Responsibilities include serving as the main point of contact, leading local study teams, and collaborating with external partners. A Bachelor's degree in Science and solid experience in clinical research management are required. This role also requires fluency in English and offers opportunities to further develop your career in clinical trials.

Qualificações

• Solid experience in Clinical Research management.
• Experience in immunology study is a plus.
• Experience as CRA monitoring clinical trials.

Responsabilidades

• Main Point of Contact for assigned protocols in country.
• Project management of assigned studies and tracking execution.
• Ensures compliance with key systems in assigned studies.
• Collaborates with functional outsourcing vendors and investigators.

Conhecimentos

Clinical Research management

CRA monitoring experience

Fluency in English

Formação académica

Bachelor's degree in Science

Descrição da oferta de emprego

This role is primarily accountable for the end to end performance and project management for assigned protocols in a country in compliance with ICH / GCP and country regulations, company policies and procedures, quality standards and adverse event reporting requirements internally and externally.

For certain studies, the CRM could be responsible for several countries in a cluster.

Responsibilities

• Main Point of Contact (POC) for assigned protocols and link between Country Operations and clinical trial team (CTT).
• Responsible for project management of the assigned studies: pro‑actively plans, drives and tracks execution and performance of deliverables / timelines / results to meet country commitments from feasibility and site selection, recruitment, execution and close out.
• Accountable for performance for assigned protocols in a country in compliance with ICH / GCP and country regulations, company policies and procedures, quality standards and adverse event reporting requirements internally and externally.
• Reviews Monitoring Visits Reports and escalates performance issues and training needs to CRA manager and / or functional vendor and internal management as needed.
• Performs Quality control visits as required.
• Leads local study teams to high performance: trains in the protocol other local roles, closely collaborates with and supports CRAs as protocol expert and coordinates activities across the different local country roles ensuring a strong collaboration.
• Responsible for creating and executing a local risk management plan for assigned studies.
• Ensures compliance with CTMS, eTMF and other key systems in assigned studies.
• Escalates as needed different challenges and issues to TA Head / CRD / CQM and or CTT (as appropriate).
• Responsible for collaboration with functional outsourcing vendors, investigators, other external partners in assigned studies.
• Country POC for programmatically outsourced trials for assigned protocols.
• Serves local business needs as applicable in his / her country (If delegated can sign contracts and manage budgets).
• Collaborates internally with HQ functions and locally with PV, Regulatory and GMA to align on key decisions in his / her studies.
• As a customer‑facing role, this position will build business relationships and represent company with investigators.
• Shares protocol‑specific information and best practices across countries\clusters.

GHH to be consulted as needed.

Experience Requirements

• Solid experience with Clinical Research management and Desirable, experience in immunology study.
• Solid previous experience as CRA monitoring clinical trials.

Educational Requirements

• Bachelor's degree in Science.

Preferred

• Advanced degree, (e.g. BA / BS or higher) with a strong emphasis in science and / or biology.
• Fluency in English.