Sr Site Manager / Sr Clinical Research Associate

Johnson & Johnson; São Paulo; Teletrabalho; BRL 60.000 - 100.000; Tempo integral

Resumo da oferta

Join a forward-thinking company dedicated to advancing healthcare solutions through innovative medicine. As a Senior Site Manager, you will play a crucial role in managing clinical trials, ensuring compliance, and championing patient care. This position offers the opportunity to work independently while collaborating with a talented team focused on developing life-saving treatments. Your expertise will help shape the future of healthcare, making a profound impact on patients' lives. If you're passionate about clinical research and eager to contribute to meaningful advancements, this role is perfect for you.

Serviços

Flexible Work Hours

Health Insurance

Professional Development Opportunities

Travel Allowance

Remote Work Options

Qualificações

• Minimum of BA or BS in related field required.
• At least 2 years of clinical research monitoring experience desired.

Responsabilidades

• Acts as primary contact for assigned sites and ensures compliance.
• Responsible for site initiation, monitoring, and close-out activities.

Conhecimentos

Clinical Research Monitoring

GCP Knowledge

Communication Skills

Problem-Solving

IT Proficiency

Formação académica

BA or BS in Pharmacy

BA or BS in Nursing

BA or BS in Life Sciences

Ferramentas

Clinical Trial Management Systems

Data Entry Systems

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 5 positions of Sr Site Manager / Sr Clinical Research Associate (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. A Senior, Site Manager is assigned to trial sites to ensure inspection readiness through compliance with the clinical trial protocol, company SOPs, GCP, and applicable regulations and guidelines from study start-up through to site closure. Responsibilities may include assisting with site selection, site qualification assessment, subject recruitment and retention planning, site initiation, on-site and remote monitoring and close-out activities. The Senior, Site Manager will partner with the Local Trial Manager (LTM), Clinical Trial Assistant (CTA) and TDL (Trial Delivery Leader) to ensure overall site management while performing trial related activities for assigned protocols. A Senior, Site Manager may contribute to process improvement, training and mentoring of other Site Managers. A Senior, Site Manager is generally expected to operate independently with little or limited supervision.

Principal Responsibilities:

1. Acts as primary local company contact for assigned sites for specific trials.
2. May participate in site feasibility and/or Site Qualification Visit.
3. Attends/participates in investigator meetings as needed, may help prepare meeting materials and may be required to present at the IM.
4. Responsible for executing activities within site initiation and start-up, preparation and conduct of site monitoring (including remote monitoring), site management (by study specific systems and other reports/dashboards) and site/study close-out according to SOPs, Work Instructions (WIs) and policies. Responsible for implementing analytical risk-based monitoring at the site level and working with the site to ensure timely resolution of issues found during monitoring visits. Able to implement and execute all tasks independently with little or limited supervision.
5. Ensures site staff are trained and the training records are complete and accurate at all times. Responsible for activities during site activation to speed up the process and activate the site in the shortest possible timeframe. May help provide solutions to challenges faced in other sites in the country.
6. Contributes to site-level recruitment strategy, contingency planning, and implementation in partnership with other functional areas.
7. Ensures site study supplies are adequate for trial conduct.
8. Ensures clinical drug supplies are handled, stored, and returned properly, with accurate inventory and documentation.
9. Arranges for the appropriate destruction of clinical supplies.
10. Ensures site staff complete data entry and resolve queries within expected timelines.
11. Ensures accuracy, validity, and completeness of data collected at trial sites.
12. Proactively reports all AEs/SAEs/PQCs within required timelines, ensuring consistency with source documents.
13. Maintains complete, accurate, and timely data and documents in relevant systems.
14. Documents trial activities, writes visit reports and follow-up letters, and communicates issues to stakeholders.
15. Reviews study files for completeness and ensures proper archiving and storage.
16. Collaborates with LTM to document and communicate site/study progress and issues.
17. Attends team meetings and trainings regularly.
18. Complies with training requirements. Acts as local expert in assigned protocols with sufficient therapeutic knowledge.
19. Works with LTM on CAPA for QA audits and quality issues, may oversee audit and inspection prep.
20. Prepares trial sites for closeout, conducts final closeout visit.
21. Tracks costs at site level and ensures payments if applicable.
22. Establishes and maintains good relationships with stakeholders, investigators, and site staff.
23. May participate in HA and IRB submissions and notifications.
24. Acts as a point of contact in site management practices, providing credible insights.
25. May serve as a coach or mentor to less experienced site managers.
26. Contributes to process improvement and training.
27. Leads or participates in special initiatives as assigned.
28. May assume additional responsibilities such as “Champion” or Subject Matter Expert”.

Education and Experience Requirements:

Minimum of a BA or BS in Pharmacy, Nursing, Life Sciences, or related field (or equivalent experience) is required.

At least 2 years of clinical research monitoring experience in phase 2/3 studies is desirable.

Therapeutic area experience (oncology/hematology) may be required.

Strong knowledge of GCP, SOPs, local laws, and protocols is essential.

Strong IT skills and proficiency in company systems are required.

Willingness to travel (75%) with occasional overnight stays.

Proficiency in the local language and English, with good communication skills.

Ability to manage multiple trials and demonstrate effective communication, problem-solving, and consistent delivery in clinical trials.