Senior Site Manager

Johnson & Johnson; São Paulo; Presencial; BRL 80.000 - 120.000; Tempo integral

Resumo da oferta

Une entreprise leader dans le domaine de la santé recherche un Senior Site Manager pour superviser les essais cliniques. Ce rôle exige une expertise en conformité et gestion de projets, avec des responsabilités allant de la sélection des sites à la formation du personnel. Le candidat idéal aura une formation en sciences de la vie et une expérience pertinente en gestion d'essais cliniques.

Qualificações

• 2+ ans d'expérience en surveillance d'essais cliniques, 3-5 ans préférés.
• Connaissance approfondie des GCP, SOP et lois locales.
• Capacité à gérer plusieurs essais et à livrer des résultats.

Responsabilidades

• Agir en tant que contact principal pour les sites assignés.
• Participer aux visites de faisabilité et de qualification.
• Gérer les activités d'initiation, de surveillance et de clôture des sites.

Conhecimentos

Conformité

Gestion de projets

Communication

Formação académica

BA ou BS en pharmacie, soins infirmiers, sciences de la vie

Ferramentas

Logiciels pertinents

Descrição da oferta de emprego

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:

R&D Operations

Job Sub Function:

Clinical Trial Support

Job Category:

Professional

All Job Posting Locations:

São Paulo, Brazil

Job Description:

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at: https://www.jnj.com/innovative-medicine

We are searching for the best talents for these 6 positions of Senior Site Manager (home based).

Purpose:

A Senior, Site Manager is a mid-level site management role with typically 3-5 years of experience. This role serves as the primary contact point between the Sponsor and the Investigational Site. Responsibilities include ensuring inspection readiness, compliance with protocols, SOPs, GCP, and regulations from start-up to site closure. Tasks may involve site selection, qualification, recruitment, initiation, monitoring, and close-out. The Senior, Site Manager partners with local and central teams, may contribute to process improvements, and is expected to operate independently with minimal supervision.

Principal Responsibilities:

1. Acts as the primary local company contact for assigned sites.
2. Participates in site feasibility and qualification visits.
3. Assists in investigator meetings, including preparation and presentation.
4. Executes site initiation, monitoring, management, and close-out activities according to SOPs and policies, implementing risk-based monitoring and resolving issues independently.
5. Ensures site staff training and maintains training records.
6. Contributes to recruitment strategies and contingency planning.
7. Manages clinical supplies and ensures proper handling and storage.
8. Ensures accurate data entry, query resolution, and data quality.
9. Reports adverse events and maintains trial documentation and archiving.
10. Collaborates with teams on site/study progress and issues.
11. Participates in team meetings and training.
12. Acts as a local protocol expert with sufficient therapeutic knowledge.
13. Supports quality assurance activities and site audits.
14. Prepares sites for close-out and manages costs and payments.
15. Builds relationships with stakeholders and may participate in health authority submissions.
16. Provides insights and mentorship, and may lead special initiatives or serve as a subject matter expert.

Education and Experience Requirements:

• BA or BS in Pharmacy, Nursing, Life Sciences, or related field (or equivalent experience).
• 2+ years of clinical trial monitoring experience; 3-5 years preferred.
• Therapeutic area experience is advantageous.
• Strong knowledge of GCP, SOPs, local laws, and protocols.
• Proficiency in relevant software and willingness to travel.
• Fluent in the local language and English, with good communication skills.
• Ability to manage multiple trials and deliver results effectively.