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Sr. Clinical Study Administrator

2 semanas atrás

São Paulo, Brasil AstraZeneca Tempo inteiro

The Clinical Study Administrator (CSA) plays a crucial role in coordinating study activities from start-up to execution and close-out within Country Operations Management (COM). This ensures the quality and consistency of trial deliverables, meeting time, cost, and quality objectives according to Good Clinical Practices (GCP), AstraZeneca Standard Operating Procedures (SOPs), and evolving regulatory requirements. The CSA collaborates closely with the Project Manager Country Operations (PMCO) and other local study team members in COM, such as the Study Start-Up (SSU) manager, Clinical Research Associates (CRA), Site Management Leads (SML), and Head of Country Operations (HCO), to support the conduct of clinical trials in the region or country.

**Accountabilities**
- Providing support to the local study team in COM to achieve quality and timeliness of study deliverables across the lifecycle of assigned trials (site identification, feasibility, start-up, recruitment, data deliverables, filing of complete study documentation).
- End-to-end electronic Trial Master File (eTMF) set-up and maintenance, regulatory document tracking, tracking of team training documentation, milestone management in the Clinical Trial Management System (CTMS), and other general trial support in the country or region as delegated or per assigned trials.
- Providing support to the local study team for start-up activities in the start-up phase: CDA delivery and negotiation, distribution and collection of documents, communication with sites during contract negotiation phase, Site File preparation, and preparation and approval of sites for activation.
- Collaborating with PMCO, CRAs, SSU manager, and study vendors on the preparation, handling, and distribution of clinical trial supplies and maintenance of tracking information.
- Acting as a central point of contact for the local study team in COM for designated project communications, correspondence, and associated documentation.
- Inputting on the development and maintenance of project management and other global tracking tools (e.g., CTMS, smartsheets).
- Collaborating in global initiatives to standardize processes within and across countries (collaboration with other local and global CSAs).
- Assisting with local language translations, IRB/CEC/CA submissions in collaboration with Regulatory Affairs and other functions as required within the country/region.
- Providing support to the local COM team with local F2F study and team meetings (venue, cost, agenda), supporting team teleconferences, and assisting with staff onboarding as required by country/region.
- Depending on the country/region, providing varying levels of COM support to the department rather than to assigned studies as needed.

**You will need to have**:

- Bachelor's Degree in a related discipline, preferably life science.
- Excellent written and verbal communication skills in both local language and in English (mandatory)
- Proficiency with MS Office Suite (Excel, Word, PowerPoint).
- Understanding of the drug development process either via education or experience in the life sciences field.
- Preferably senior experience in Development.
- Excellent collaboration and interpersonal skills, unafraid to ask questions.
- Strong organizational skills and ability to manage competing priorities.
- Strong attention to detail.
- Effective written and verbal communication skills.

**We would prefer for you to have**:

- Prior experience working in clinical research.
- Medical knowledge and ability to learn relevant Astrazeneca rare disease areas.
- Ability to work in an environment of remote collaborators and in a matrix reporting structure.
- Manages change with a positive approach for self, team, and the business. Sees change as an opportunity to improve performance and add value to the business.
- Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time.
- Team-oriented and flexible; ability to respond quickly to shifting demands and opportunities.
- Ability to understand the impact of technology on projects and to use and develop computer skills while making appropriate use of systems/software in an e-enabled environment.

At AstraZeneca's rare diseases division, you will find an environment where work is more than just a job. Our commitment to patients drives us to innovate continuously. We offer a unique blend of biotech's entrepreneurial spirit with the stability of a global pharma company. Here, you will be encouraged to take ownership of your career path, develop new skills, and expand your capabilities. Our culture is built on integrity, inclusiveness, and a dedication to making a difference for those living with rare diseases.