Associate Clinical Data Manager

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries. JOB DESCRIPTION: Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life.   You’ll   also have access to:

• Career development with an international company where you can grow the career you dream of.
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with high employer contribution
• Tuition reimbursement, the   Freedom 2 Save   student debt   program   and   FreeU   education benefit - an affordable and convenient path to getting a bachelor’s degree.
• A company recognized as   a great place   to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists. For years, Abbott’s medical device businesses have offered technologies that are faster, more effective, and less invasive. Whether   it’s   glucose monitoring system, innovative therapies for treating heart disease, or products that help people with chronic pain or movement disorders, our medical device technologies are designed to help people live their lives better and healthier. Every day, our technologies help more than   10,000 people   have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than   500,000 people   with diabetes from routine   finger   sticks.

The Opportunity

Our location in   Maple   Grove   MN   currently has an on-site opportunity for a n   Associate Clinical Data Manager .    As the customer-face of   the   Data Review   team   and its primary liaison with the   Clinical   p roject   t eam , 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 rel ated 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’ e xperience in   c linical 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 . 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. JOB FAMILY: Clinical Affairs / Statistics DIVISION: MD Medical Devices LOCATION: United States > Maple Grove : 6820 Wedgwood Road N. ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Yes, 5 % of the Time MEDICAL SURVEILLANCE: No SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday) Abbott is an

Equal Opportunity

Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans. EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf