Apex Systems, Inc. Senior Clinical Data Associate 1154361 in Maplewood, Minnesota
Role: Senior Clinical Data Associate Location: Remote - 100% telecommute long-term (can sit / remote work anywhere in the US) Organization: Fortune 500 An innovative technology company, which manufactures industrial, safety and consumer products Length: Long-term renewable contract Compensation: $62,000 - $66,000 range depending on experience, qualifications, certifications, etc. Additional Details/Perks: As a Contractor with Apex, you d have access to two additional training programs, healthcare benefits, 401K, employee stock purchase program, weekly pay, and other benefits. Job Description: Senior Clinical Data Associate A Senior Clinical Data Associate team member is a highly motivated, eager, humble, positive, solutions-oriented individual. The Senior Clinical Data Associate provides input and support for department and project activities as an individual contributor. Responsibilities Senior Clinical Data Associate The Senior Clinical Data Associate supports the Clinical Data Management department with the study start-up, data collection and cleaning, and database lock activities for one or more studies. In this role, the Senior Clinical Data Associate assists the Clinical Data Manager with database builds including testing and validation, data collection, as well as the planning for and execution of data review and cleaning, and data querying. Participate in CRF design and database development activities including creation and/or review of requirements/specifications, assisting with test data/script creation, and database validation and test script execution. Assist with the creation and/or review of data management specific study documentation (e.g. CRF Completion or Data Entry Guidelines, Data Management Plan, and Data Review Plans). Evaluate data entered into clinical study databases in accordance with study specific documentation and data review plans. Contribute to the review of data listings for data quality, content, format, and database output. Assist the cross-functional study team in identifying data issues during study data collection, post queries, and review query resolutions in preparation for database lock. Update study logs and tracking forms. Communicate project status, data quality, and key data collection issues or findings to management and the cross-functional study team. Accountable for ensuring that deliverables and timelines are met while providing high quality results. Works with manager to set challenging, achievable goals which contribute to department objectives. Actively participates in department and project team meetings and activities Provides input to the study team and offers solutions to project challenges. Maintain awareness of industry standards (such as ICH/GCP and ISO), regulatory requirements (such as CFR, ISO, and MDR), and departmental operating procedures. Participates in process improvement initiatives. Flexibility in shifting priorities according to company needs. Perform activities and tasks as directed by supervisor.