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Abbott Point of Care is a worldwide leader in providing with-patient care solutions that are intuitive, reliable, and cost-effective for our customers. By delivering lab-quality results in minutes, our i-STAT® System family of with-patient products and services fosters a collaborative, patient-centered environment while driving operational performance. We are headquartered in Princeton, New Jersey, with more than 1,500 global employees and a presence in 84 countries. Our 46,500 square meter, state-of-the-art manufacturing and research facility, Abbott Point of Care, is located in Ottawa, Ontario, Canada.
Status : Fulltime/Temporary (2 year contract)
The Clinical Data Management Analyst is responsible for most aspects of data management activities in support of assigned clinical studies. Ensures that quality of services meets internal and external customer requirements.
Working under general supervision, is 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.
With appropriate manager oversight, 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
• Additional study specific activities
• Ensures that all data management activities for assigned studies are completed on time and 48Twith 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 and other regulatory requirements.
Required Education and Experience:
Minimum 0-2 years in an engineering role.
Bachelor's Degree (Science, Engineering or related discipline)
Demonstrated initiative and problem-solving skills; critical thinking skills;
Intermediate working knowledge of MS Office,
Programming experience in any of the following SAS, SAS JMP, R, Python
Excellent Communications skills, both oral and written.
Ability to design experiments, analyze and interpret data, and document conclusions;
Analytical skills, creativity and innovative approach to problem solving;
Ability to collaborate effectively with multidisciplinary team members and also to work independently;
Willingness to work in labs, manufacturing areas, and office environments;
Very strong investigational skills, drive to understand and solve problems;
Propensity for continuous learning and experimentation.
Abbott Canada is committed to the hiring, advancement and fair treatment of individuals without discrimination based on factors such as race, sex, colour, ethnic or national origin, religion, disability, age, citizenship, family or marital status, political beliefs, sexual preference or other factors included in human rights legislation.
Our diversity goals for recruitment, hiring, and retention are embedded in our corporate goals, and our diversity initiatives are supported by the highest level of the organization.
We strongly believe that a diverse workforce fosters more creative and innovative thinking throughout the organization. Creating an inclusive environment, where everyone is respected and valued, enables us to leverage our diversity as a business driver and strengthens our position as a global leader.
Abbott strives to promote and maintain an inclusive, high-performing culture that allows all employees to reach their full potential and contribute to Abbott's success.