Manager, Clinical Data Review – Medical Devices (On-site)
Locations: Maple Grove, MN | Sylmar, CA
Category: Medical & Clinical Affairs
Company Overview:
Abbott is a global healthcare leader committed to helping people live healthier, fuller lives at every stage. Our portfolio includes diagnostics, medical devices, nutritionals, and branded generic medicines. With 114,000 colleagues in over 160 countries, Abbott develops innovative technologies that improve patient outcomes, enhance quality of life, and transform healthcare worldwide.
Role Overview:
Abbott is seeking a Manager, Clinical Data Review – Medical Devices to lead an on-site team responsible for clinical study data management. This role will oversee all aspects of clinical data, including Case Report Form (CRF) design, edit check specifications, data cleaning, dataset preparation, and reporting for analysis. The Manager ensures data integrity, compliance with regulatory requirements, and alignment with Abbott’s business and scientific objectives.
The successful candidate will combine strong leadership, technical expertise, and operational insight to optimize clinical data processes, monitor team performance, and deliver high-quality datasets for clinical development and regulatory submissions.
Key Responsibilities:
Lead, mentor, and develop a diverse team of clinical data professionals; provide performance feedback, coaching, and career development.
Oversee data entry, data cleaning, and clinical database management to ensure data integrity and protocol compliance.
Manage CRF design, edit check specifications, and other data collection requirements.
Collaborate with cross-functional teams to provide clinical database outputs for Development, Marketing, and other departments.
Monitor and report project status to executive management; ensure adherence to quality standards and regulatory requirements.
Stay current with industry trends, regulatory requirements, and best practices in clinical data management; train staff on new developments.
Support Company initiatives, including Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory standards.
Foster a safe, professional, and collaborative work environment while maintaining high standards of ethical behavior.
Required Qualifications:
Bachelor’s degree in a science-related field, or equivalent combination of education and experience.
Minimum 8 years of progressively responsible experience in pharmaceuticals, biotechnology, or medical devices, including clinical data management.
Advanced proficiency in databases, word processing, graphics, and authoring software.
Strong leadership skills with the ability to set goals, provide constructive feedback, and build high-performing teams.
Excellent verbal and written communication skills, with the ability to interact effectively at all organizational levels.
Strong organizational, planning, and prioritization skills; ability to meet deadlines in a fast-paced, matrixed environment.
Preferred Qualifications:
Experience managing clinical data across multiple business units or enterprise-level operations.
Compensation:
Base salary range: $97,300 – $194,700. Location-specific variations may apply.
Why Abbott:
At Abbott, you’ll have opportunities to grow your career, access comprehensive health benefits, participate in tuition reimbursement programs, and work in an inclusive, globally recognized company. Abbott is committed to diversity, equity, and inclusion, and provides an environment where employees can thrive professionally and personally.
This version:
Highlights management and clinical data expertise for SEO and GPT indexing.
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Emphasizes leadership, regulatory compliance, and operational excellence.
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