Senior Cta

il y a 3 semaines


Colombes, France Oracle Temps plein

Senior CTA-230003ZV

**Applicants are required to read, write, and speak the following languages***: English

**Preferred Qualifications**

**Cerner Enviza, part of Oracle, is a leading global healthcare consulting firm and trusted advisor to many of the world’s top pharmaceutical, biotech, and medical device & diagnostic companies. By supporting the work of Cerner Enviza, you will work with world-class healthcare companies, helping them improve global access to medicines by connecting science and research. Cerner Enviza is passionate about our people, our business, and our clients and is proud to foster a culture that contributes to the health and well-being of humankind.**

**With ongoing and ground-breaking developments in Oncology and Rare Disease, an increased focus on more scientific, targeted medicine and continuous integration of technology into development and delivery of medicine, there has never been a more exciting time to work in Life Sciences and, with Cerner Enviza immersed in all of these, there has never been a better time to join us and make a difference to our clients and the lives of patients.**

**KEY OUTCOMES**

The Clinical Trial Assistant supports the Project Manager and the Lead Clinical Research Associate (CRA) in the conduct of national and international projects (non-interventional and clinical studies) with administration and logistic support
- Close support in administrative and project management related activities
- Support in preparation of documents for the submission and notification process of Ethics Committees and Regulatory Bodies
- Preparation of Trial Master Files and Investigator Site Files
- Maintenance of both paper and electronic Trial Master Files
- Maintain study data bases, study management tracker, filing, documentation, and archiving
- Support monitoring of project milestones and progress
- Assistance with invoicing and payment procedures
- Coordinate and conduct mailings and phone activities
- Prepare and coordinate meetings (internal and external) including writing meeting minutes
- Coordinate internal communication flow and workflows
- Close contact with the study team, study sites and CRAs
- Supporting function for data handling processes
- Administration of clinical trials according to good clinical practices and standard operating procedures

***

**Education**:

- Bachelor's degree in Life Sciences, Medical, Pharmacy or Public Health or
- relevant professional education or
- completed professional education plus 2 years practical experience

**CAPABILITIES**
- Initial practical experience in clinical research of advantage
- Basic knowledge in the conduction of interventional and non-interventional studies would be beneficial.
- Basic knowledge of clinical research concepts, practices, and ICH/ GCP Guidelines regarding drug development phases, clinical research and data management methods
- Read, write and speak fluent English and French; good verbal and written communication skills
- Very good knowledge of MS Office
- High commitment, high load capacity and flexibility
- Excellent organizational and communication skills
- Highly service oriented
- Careful, precise and independent work as instructed
- Strong team player skills and cross-cultural competence
- Capable of multitasking

**Detailed Description and Job Requirements**

Responsible for conducting applied research in scientific area of focus. Investigating applicable solutions through rigorous, protracted studies and ensuring that a quality, integrated solution is delivered in a timely manner, at budget, and to our client*s satisfaction. This involves working closely with the client to understand and manage their expectations, as well as working closely with Oracle and third-party vendors to ensure delivery.

Entry-level position for those who are new to consulting and are developing their expertise. Receives detailed instruction on routine work and is responsible for performing basic experiments and test on research topic and documenting results. As a member of a project team, follows standard practices and procedures to evaluate and analyze data, develop reports and presentations in external customer engagements. Uses available tools to analyze and solve problems for clients. May perform other duties as assigned.

Bachelors or Advanced degree in a discipline relevant to area of focus, plus 1 year related work experience. Minimum Qualifications: At least 4 years Total combined related work experience and completed higher education. Depending on the job there may be additional minimum requirements and/or preferred qualifications

**Job**: Consulting

**Location**: FR-FR,France-COLOMBES CEDEX

**Job Type**: Regular Employee Hire

**Organization**: Oracle



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