Clinical Data Coordinator Job in Actalent Orange, CA
This Jobsfunter Listing is about Actalent in Orange, CA 2022
About the job
- Responsible for most aspects of data management activities in support of assigned clinical studies.
- These activities help to ensure high quality data is achieved in support of analysis for regulatory submissions, safety monitoring and publications.
- Ensures that Good Clinical Practices (GCP), Good Clinical Data Management Practices (GCDMP) and established processes are followed.
- Identifies and routinely uses the most effective, cost efficient and best business practices to execute processes; continually evaluates their effectiveness and appropriateness.
- Exercises judgment in planning, organizing and performing work; monitors performance and reports status within area of responsibility.
- Ensures that quality of services meets internal and external customer requirements.
- Performs all data management activities for assigned studies
- Case Report Form (CRF) development and maintenance
- Edit Check specifications development and maintenance
- Data Management Plan development and maintenance
- Data Quality checks and discrepancy management
- Analyzes data, identifies trends; prepares data tables for clinical reports
- Database setup testing and Edit Check programming testing
- External data handling
- Elements of device reconciliation
- Participate in Post Market Surveillance reporting as appropriate
- Ensures that all data management activities for assigned studies are completed on time and with high quality or escalates as appropriate
- Communicates well with peers, study teams and management as appropriate to support studies and goals
- Represents the Data Management group at study team meetings
- Applies best practices and established standards
- Has a general understanding of the clinical trial process and regulations that apply, engages in relevant professional associations or societies, and seeks continuing education about SJM devices and therapies.
- Communicates and collaborates with all levels of employees.
- Follows departmental Standard Operating Procedures (SOPs), Departmental Work Instruction (DWIs), and guidelines.
- Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
- Complies with U.S. Food and Drug Administration (FDA) regulations, International Conference on Harmonisation (ICH), ISO 14155, other regulatory requirements, applicable company policies, operating procedures and processes.
Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions. The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
Vacancy Type: Full-time · Entry level
Job Location: Orange, CA
Application Deadline: N/A