The Opportunity

Our location inMapleGroveMNcurrently has an on-site opportunity for anAssociate Clinical Data Manager. As the customer-face oftheData Reviewteamand its primary liaison with theClinicalprojectteam, theAssociateClinical Data Manager9s in-depthclinical operations andtherapy-specific knowledge ensures alignment to customerneeds, andinforms review and analysis of study data.

WhatYou9llWork On

• Leads andfacilitatesan ongoing evaluation of risk involving in-depth review of protocol and plan documentation, discussion and validationrisk-related findings with cross-functional workgroup, and the development of systems and process-based controls to mitigateidentifiedrisks. These responsibilities include:

• Leading cross-functional teams during protocol development toidentifyand document those data which are critical to the reliability of study results and the protection of human subjects

• Managing the development and revision of the critical processes (e.g.CRF design, Edit Checks, data listings, and clinical database setup) by which those data will be captured and managed throughout the clinical investigation

• Identifyingand evaluating residual risks to critical study data and supervising the development ofadditionalmitigations including focused data cleaning and quality activity, targeted site instruction, and study-specific Central and Site Monitoring plans

• Leads the Clinical Project Team through the development of Case Report Forms and partners with the Study Database Manager through study database development and release, includingidentifying,programmingand testing edit checks.

• Conducts complex review and analysis of subject data as it accumulates, resolving discrepant or aberrant data points via individual queries to study sites, as well as the identification of systemic and/or significant data quality issues requiring escalation; manages escalation efforts and drives them to resolution in partnership with Project Management, Site Management, Clinical Science, Biometrics, Safety, and organizational leaders.

• Manages progress towards data cleaning and data freeze/lock targets for regulatory submission, and other business needs asidentifiedby the Clinical Project Team.

• Manages, with dedicated support of the Clinical Data Coordinator, the study-wide issuance and resolution of discrepancies over the study lifecycle.

• Overseesthe maintenance of data review standards and best practices, ensuring adherence informed by therapy-specificexpertise.

• Leads proactive partnership, on both an ad hoc and period/prescribed basic, with field and study team personnel, presenting findings and issues uncovered during data review, devising and documenting appropriate resolution and escalation strategies, and managing the overall health of data quality and study conduct through milestones and deliverables over the lifecycle of the study.

Required Qualifications

• Bachelor9s degree in a related fieldOR an equivalent combination of education and work experience.

• Minimum 4years9related workexperiencewith a solid understanding of specified functional area.

• Broad knowledge and application of business concepts,proceduresand practices.

• Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations.

• Learnsto use professional concepts and company policies and procedures to solve routine problems.

• Works on problemsoflimited scope.Independent decision makingrequired.

PreferredQualifications

• Bachelor9sdegree inbusiness administration, datascience,statisticsor life sciences.

• 3-5 years9 experience inclinical operations or healthcare related field

• Strong verbal and written communications withabilityto effectively communicate at multiple levels in the organization.

• Excellent analytical skills and ability to manage complex tasks and manage time effectively.

• Prior data management experiencerequired.