Associate Clinical Data Manager

About the Opportunity

Our location in Maple Grove, MN currently has an on-site opportunity for an Associate Clinical Data Manager. As the customer-face of the Data Review team and its primary liaison with the Clinical project team, the Associate Clinical Data Manager's in-depth clinical operations and therapy-specific knowledge ensures alignment to customer needs, and informs review and analysis of study data.

What You'll Work On

Leads and facilitates an ongoing evaluation of risk involving in-depth review of protocol and plan documentation, discussion and validation risk-related findings with cross-functional workgroup, and the development of systems and process-based controls to mitigate identified risks. These responsibilities include:

• Leading cross-functional teams during protocol development to identify and 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
• Identifying and evaluating residual risks to critical study data and supervising the development of additional mitigations 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, including identifying, programming and 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 as identified by 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
• Oversees the maintenance of data review standards and best practices, ensuring adherence informed by therapy-specific expertise
• 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

• Bachelor's degree in a related field OR an equivalent combination of education and work experience
• Minimum 4 years' related work experience with a solid understanding of specified functional area
• Broad knowledge and application of business concepts, procedures and practices
• Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations
• Learns to use professional concepts and company policies and procedures to solve routine problems
• Works on problems of limited scope
• Independent decision making required

Preferred Qualifications

• Bachelor's degree in business administration, data science, statistics or life sciences
• 3-5 years' experience in clinical operations or healthcare related field
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization
• Excellent analytical skills and ability to manage complex tasks and manage time effectively
• Prior data management experience required

Pay

The base pay for this position is $78,000.00 – $156,000.00. In specific locations, the pay range may vary from the range posted.