Evidence Generation Specialist

Há 7 dias

Sao Paulo, Brasil AstraZeneca Tempo inteiro

AstraZeneca is one of the most fascinating biopharmaceutical companies in the world. From researchers to sales people, from lab technicians to the legal department, we all have a mission to turn ideas into science, science into revolutionary medicines that save and extend patients’ lives and benefit society. Our portfolio is solid and our pipeline is innovative with a focus on biological medicines in the Cardio-Metabolic, Respiratory and Oncology areas.

The Project Manager is in charge to lead and manage projects that support the areas in strategic projects, as well as, responsible for all phases of a project including business justification, project initiation, planning, execution and closure in partnership with leader of each area.

**Responsibilities**:

- The Evidence Generation Specialist is responsible for leading execution activities of evidence generation studies in order to guarantee the quality and consistency of the project as a whole through activities that range from negotiating the study with vendors to completing the publication of the studies.
- Contributes to the monitoring, review, and closure of operational activities related to Externally Sponsored Research (ESR) and the Early Access Program, when necessary.
- Monitors compliance by team members and third parties, as well as positively enforces the Code of Conduct and all relevant legal and regulatory requirements of AstraZeneca Policies and Standards.
- Activities developed under the supervision of the department manager.
- Lead the identification and contracting of external suppliers.
- Lead the high risk study execution since the study design concept, study execution, including governance process, vendor management until the study publication.
- Lead and review the set-up of the Trial Master File (TMF/eTMF) including tracking of documents. Maintain and close the TMF/eTMF ensuring International Conference of Harmonisation Guidelines for Good Clinical Practice (ICH/GCP) compliance.
- Lead the practical arrangements and contribute to the preparation of internal and external meetings e.g. study team meetings, monitor meetings, Investigator meetings. Liaise with internal and external participants and/or vendors.
- Lead all project payments flows according to contract agreements and project milestones.
- Responsibility to contribute with the GxP areas to ensure the legal and regulatory requirements of evidence generation roles in providing appropriate resources (which could be human, financial, material, facilities, and equipment) to maintain the Quality system and continually improvement; able to perform self-assessment according to internal and regulatory expectations, identify observations and improvement opportunity within the audit process.
- Lead study close out, study information and records archiving.

**_
Requirements:_**
- Bachelor’s degree in health area required
- Advanced spoken and written English
- GCP/ICH and Local regulation knowledge required
- Project management skills
- At least 3 years of previous experience from Clinical Operational Activities (regulatory, start up and / or clinical monitoring tasks)

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