Monitor Pesquisa Clinica Senior

Abbvie; São Paulo; Presencial; BRL 80.000 - 100.000; Tempo integral

Resumo da oferta

A biopharmaceutical company in São Paulo is seeking a Clinical Research Associate to oversee site monitoring and execution of clinical trials. This role includes ensuring compliance with local regulations, mentoring CRAs, and collaborating with stakeholders throughout the study. The ideal candidate has at least 3 years of monitoring experience and a Bachelor's degree in a health-related field. Strong analytical skills and the ability to adapt to changing environments are essential for success in this role.

Qualificações

• Minimum 3 years of site monitoring experience.
• Strong analytical and critical thinking skills.
• Ability to organize and manage competing projects flexibly.

Responsabilidades

• Ensure protocol level execution of SMM deliverables.
• Anticipate site issues and develop solutions.
• Mentor and coach CRAs for development.

Conhecimentos

Site Monitoring Experience

Analytical skills

Planning and organizational skills

Business ethics and integrity

Formação académica

Bachelor's degree in health related field

Descrição da oferta de emprego

Company Description

To enable AbbVie's emergence as a world class R&D organization, the position plays a key role in ensuring successful protocol level execution of SMM deliverables involving start-up, execution, and close‑out of studies.

For assigned sites / study(s), ensure successful protocol level execution of SMM deliverables involving start-up, execution, and close‑out.

Ensure site related study execution including but not limited to monitoring visits, site evaluations, site selection, and activation, and monitoring close out and visit reports.

Anticipate and identify site issues that could affect timelines and develop alternative solutions.

Provide Local regulatory and legal requirement expertise.

Ensures timely payment execution for the assigned sites / study(s) according to the clinical study agreements and as per local requirements.

• Ensure clinical trial management systems containing all sitespecific information are maintained and kept current.
• Ensure adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), Monitoring Plans, and to quality standards in conducting clinical research.
• Ensure audit and inspection readiness of assigned sites.
• Responsible for coaching and mentoring CRAs and providing input into their development.
• May be responsible for being the country point of contact for CROs for an assigned study.
• If assigned; Responsible for identifying training needs and standardizing and facilitating training solutions for SMM monitors globally.
• If assigned; With guidance, may serve as key point of contact in country / district for assigned study.
• If assigned; Global Representative for a single or multiple studies, collaborating with key stakeholders to achieve proactive, strategic and tactical success throughout the study planning, execution, and closeout phases leading to World Class clinical trials.
• If assigned; Responsible for remote data review of assigned sites / studies according to the Integrated Data Review Plan (IDRP), Monitoring Plan, SOP / WI and in accordance with the study timelines and objectives.

Stay abreast of new and / or evolving local regulations, guidelines and policies.

Advise on preaudit activities for GCP requirements.

Prepare and follow up site audits / inspections; provide input into the CAPA preparation.

Responsible for mentoring CRAs for various aspects of work.

Responsible for activities as assigned by manager.

Provide consistent best practice approach to onboarding, consolidating "lessons learned" across areas and incorporating into monitoring training materials, defining best practice training curriculum, and maintaining awareness of upcoming changes to ensure effective training is delivered in a timely manner.

Update Impact / Tesla with countrylevel information : Countrylevel planning timelines, LSR assignments, etc.

Provides feedback on investigators / sites on an on‑going basis based on the site performance.

Interacts and builds professional and collaborative relationships with peers and site monitors.

Qualifications

Education : Bachelors or equivalent degree, health related (e.g. Medical, Scientific, Nursing, Pharmacy) preferred.

• Site Monitoring Experience : Minimum 3 years.
• Strong analytical and critical thinking skills to evaluate complex issues from multiple perspectives and drive smart decision making.
• Exhibits strong planning and organizational skills and high level of flexibility in a dynamic environment with competing projects and deadlines.
• Demonstrated business ethics and integrity

Additional Information

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