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Clinical Data Coordinator

Corcoran, MN 55311

Posted: 09/19/2024 Employment Type: Contract Job Category: Data Sciences Job Number: 614783 Is job remote?: No Country: United States

Job Description

Job Summary: 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.

Job Duties: List the significant/essential duties, tasks or responsibilities which employees in this position are required to perform. 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. 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. Performs other related duties and responsibilities, on occasion, as assigned.

Pay ranges between $20-22/hr based on experience 

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About Corcoran, MN

Ready to embark on a career adventure in the vibrant town of Corcoran, Minnesota? Discover exciting job opportunities in this charming area that boasts a perfect blend of small-town charm and big-city amenities. With its close proximity to Minneapolis, Corcoran offers an ideal balance of peaceful countryside living and endless entertainment options. From exploring the stunning Elm Creek Park Reserve to attending performances at the Hennepin Theatre Trust in Minneapolis, there is no shortage of cultural experiences to savor. Don't miss out on the chance to enjoy the delectable local cuisine and catch a game of the Minnesota Twins at Target Field. Embrace the unique culture and growth opportunities that Corcoran has to offer, and find your dream job today!

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.