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IN HOUSE SR SITE MANAGER - CLINICAL TRIAL ASSISTANT (CTA) - SÃO PAULO - JANSSEN

São Paulo, Brasil
Clinical Trial Administration


Descrição da Vaga

Requisition ID: 3997190906

Summary:

The Clinical Trial Assistant (CTA) supports the Local Trial Manager (LTM) and/or Site Manager (SM) to ensure optimal management of all documents with logistical and administrative tasks related to trial start-up, execution and closing of clinical trials. Ensures trial related activities are compliant with GCO SOPs, policies and local regulatory requirements. May contribute to process improvement, training and mentoring of other CTAs.

 

Principal Responsibilities:

1. Provide administrative and logistic support to LTM and/or SM in tracking process of the trial, management of study data, budget, organizing meetings, mailing and correspondence, material, drug distribution and other relevant tasks as appropriate in adherence to relevant SOPs, policies and local regulatory requirements.

 

2. Supports the local study team in performing site feasibility and/or country feasibility.

 

3. Maintains information in relevant systems.

 

4. Ensures current versions of the required trial documents, trial-related materials and supplies are provided to the investigational site within required timeframes, as applicable.

 

5. Support LTM and/or SM in collecting/preparing documents required for study start-up/submission to IEC/IRB and/or HA.

 

6. Support LTM and/or SM in collecting, processing and achiving study related documents as appropriate. Use appropriate systems to ensure file completeness at designated study milestones.

 

7. May assist LTM in conducting local investigator meeting or with making arrangements for the investigators participating in an international meeting.

 

8.Maintains and updates contact information in relevant systems to ensure appropriate safety updates distribution.

 

9. Comply with all training requirements.

 

10. Ensure inspection readiness at all times.

 

11. May contribute to process improvement including, but not limited, to representing functional area in process initiatives and contribute to optimization of daily process.

 

12. May be assigned as a coach and mentor to a less experienced CTA.




Qualificações

A minimum of a BA or BS degree in Life Sciences, Nursing or related scientific field (or equivalent experience) is required.

 

Skills set corresponding with relevant clinical trial experience is preferred; however, other relevant experiences and skills may be considered by the hiring manager when considering the candidate's eligibility.

 

Proficient in English language. Strong knowledge with MS Office.

Strong interpersonal and negotiating skills preferred.

Excellent organizational skills and the ability to collaborate and handle multiple priorities within a matrix environment.

Perform activities in a timely and accurate matter.



Local Principal
Brasil-São Paulo-São Paulo-
Organização
Janssen Cilag Farmaceutica Ltda. (7585)
Cargo
Clinical Trial Administration
Requisition ID
3997190906