We are seeking an experienced, high caliber Clinical Data Analyst I. 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.
Each employee can make a difference at St. Jude Medical and has the power, either individually or as a team, to influence the success of the company. We are team-oriented, fast-paced and progressive. We value people with great ideas who partner with others both internally and externally to take action and accomplish goals.
Impact this role will have on St. Jude Medical:
* With appropriate manager oversight, performs all data management activities for assigned studies
o Case Report Form (CRF) development and maintenance
o Edit Check specifications development and maintenance
o Data Management Plan development and maintenance
o Data Quality checks and discrepancy management
o Analyzes data, identifies trends; prepares data tables for clinical reports
o Database setup testing and Edit Check programming testing
o External data handling
o Elements of device reconciliation
o Participate in Post Market Surveillance reporting as appropriate
o Additional study specific activities
* 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.
* 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.
* Performs other related duties and responsibilities, on occasion, as assigned.
Your experience(s), education and knowledge will further expand St. Jude Medical’s marketplace success:
* Bachelor's Degree in Computer Science, Health Sciences, Informatics, related field, or equivalent.
* Typically two plus years’ experience working in a clinical research environment, experience to include a good understanding of clinical data management processes.
* Good organizational and project management skills, as well as attention to detail.
* Highly skilled with MS Office, especially Excel, Word, Publisher and Powerpoint.
* Strong ability to work with Clinical Data Management Systems.
* Understands databases; good technical skills querying and analyzing data (SQL, SAS or equivalent).
* Ability to work in a highly matrixed and geographically diverse business environment.
* Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
* Strong verbal and written communications
* Multitasks, prioritizes and meets deadlines in timely manner.
* Ability to travel approximately 5%.
* Ability to maintain regular and predictable attendance.
Your preferred qualifications and education:
* Bachelor's Degree in Computer Science, Health Sciences, Informatics, related field, or equivalent.
* Typically two plus years’ experience working in a clinical research environment, experience to include a good understanding of clinical data management processes.
**Job:** **CL-Research*
**Title:** *Clinical Data Analyst I*
**Location:** *Minnesota-Plymouth*
**Requisition ID:** *150001N9*
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