Manager, Clinical Data Review

RXinsider LTD.; Maple Grove (MN); Hybrid; USD 99,000 - 199,000; Full time

Job summary

Abbott is seeking a Manager, Clinical Data Review for on-site leadership in Maple Grove, MN. You will oversee data related to clinical studies, ensure CRF design and data integrity, and drive efficient data management practices across the team, including risk-based quality management and regulatory compliance.

The role requires guiding a diverse data management staff, mentoring subordinates, and maintaining collaboration with executive management to deliver high-quality datasets for analysis.

Qualifications

• Bachelor's degree in a science-related field or equivalent combination of education and experience.
• Minimum 8 years’ progressively responsible experience in pharma, biotech or medical device industry; apply concepts to market development.
• Advanced computer skills in graphics, word-processing, databases, authoring programs, etc.
• Experience in a matrixed, cross-divisional environment; strong leadership and communication abilities.
• Ability to travel approximately 20%, including internationally.

Responsibilities

• Lead data management for clinical studies and ensure dataset integrity.
• Oversee CRF design, edit checks and data collection requirements for analysis.
• Manage RBQM activities including risk assessments and monitoring.
• Hire, coach and mentor data management staff and subcontractors.
• Ensure compliance with FDA regulations and company policies; maintain quality metrics.

Skills

Data management leadership

Regulatory knowledge

Leadership

Communication skills

Education

Bachelor's degree in science-related field

Job description

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.

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 fingersticks.

The Opportunity

We are looking for our next Manager, Clinical Data Review to lead our team on-site out of our Maple Grove, MN. As a manager, the individual has primary management responsibility directly or through subordinates for all data related to clinical studies. This new team member will have accountability for all data entry activities, Case Report Form (CRF) design, edit check specifications, and other requirements of the Clinical databases, providing datasets and performing data cleaning for analysis. Additionally, will identify and routinely use the most effective, cost efficient and best business practice to execute processes; continually evaluate their effectiveness and appropriateness. The Manager, Clinical Data Review will exercise judgment in planning, organizing and performing work; monitor performance and report statuses to executive management as well as assures that quality of services meets internal and external customer requirements. The individual will remain current on developments in field(s) of expertise to ensure that clinical trial protocol elements are appropriately captured on CRFs and databases for analysis; responsible for ensuring database integrity.

What You’ll Work On

Responsible for hiring and retaining a diverse, highly qualified data management staff and for providing career coaching, growth, and personal development. Accountable for staff development: critiques, instructs, mentors, evaluates, and coaches. Ensures staff is appropriately trained in processes and procedures; ensures established processes and procedures are being followed and documented. Accountable for the performance of subordinates and work output of managed subcontractors. Maintains a safe work environment and a strong customer focus. Models optimum leadership competencies to inspire an energized, empowered and accountable work force, ethical behavior, favorable community image, and actualization of the Abbott Guiding Principles and values.

Manages data entry, data cleaning, data deliverables, and other data management activities.

Oversees the development of CRFs, edit check specifications, and additional data collection requirements required for tracking and analysis.

Manages the implementation and execution of Risk-Based Quality Management (RBQM) activities, including risk assessments, risk mitigation plans, data review strategies, centralized monitoring activities, and Key Risk Indicator (KRI) oversight

Manages processes to ensure data integrity via appropriate data management processes (e.g., protocol compliance reporting, querying for missing or discrepant data, evaluating data outliers, performing data quality checks, etc.).

Monitors operational performance and quality indicators; identifies trends, risks, and opportunities for improvement and implements corrective actions as needed. Remains current on developments in field(s) of expertise, regulatory requirements, and industry trends and trains staff regarding changing regulations that affect clinical studies. Maintains knowledge of current and pending regulations through literature, trade journals, professional associations, and by attending conferences.

Hires and retains a diverse, highly qualified staff and provides ongoing performance feedback. Sets goals which align to department plans and manages the execution of goals through coaching and mentoring. Maintains a safe and professional work environment.

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, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

Required Qualifications

• Bachelor's degree in a science-related field or an equivalent combination of education and experience
• Minimum 8 years’ progressively more responsible experience in the pharmaceutical, bio-technology or medical device industry; must be able to apply the fundamental concepts and practices to conduct needs assessment, research and develop information for market development purposes.
• Advanced computer skills in graphics, word-processing, databases, authoring programs, etc.
• Advanced personal computer skills (experience with Microsoft Office or equivalent required) in graphics, word-processing, databases, authoring programs, etc
• Experience working in a broader enterprise/cross division business unit model preferred. Ability to work in a highly matrixed and geographically diverse business environment. Strong leadership skills, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results. Ability to work effectively within a team in a fast-paced changing environment. Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization. Multi-tasks, prioritizes and meets deadlines in timely manner. Strong organizational, planning, and follow-up skills and ability to hold others accountable.
• Ability to travel approximately 20%, including internationally.

Preferred Qualifications

• Experience working in a broader enterprise/cross division business unit model

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives : www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews.Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

The base pay for this position is $99,300.00 – $198,700.00. In specific locations, the pay range may vary from the range posted.