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Clinical Data Coordinator
6820 Wedgewood Road North Corcoran, MN 55311 US
Job Description
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
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The 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, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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