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 dedicated to helping people live healthier, fuller lives across all stages. Our comprehensive portfolio includes diagnostics, medical devices, nutritionals, and branded generic medicines. With over 114,000 colleagues in more than 160 countries, Abbott innovates to improve patient outcomes and quality of life worldwide.
Role Overview:
Abbott is seeking a Manager, Clinical Data Review – Medical Devices to lead on-site teams in Maple Grove, MN, or Sylmar, CA. This leadership role is responsible for managing all aspects of clinical data from medical device studies, including CRF (Case Report Form) design, edit checks, data cleaning, dataset preparation, and reporting.
The Manager ensures data integrity, compliance with regulatory standards, and alignment with business objectives. This position combines strategic leadership, technical expertise, and operational oversight to deliver high-quality datasets that support clinical development and regulatory submissions.
Key Responsibilities:
Lead, mentor, and develop a diverse and highly qualified clinical data management team, providing career coaching, performance feedback, and professional growth opportunities.
Oversee clinical data processes, including data entry, cleaning, validation, and reporting, ensuring accuracy, completeness, and compliance.
Manage the development of CRFs, edit check specifications, and other data collection requirements to support study objectives.
Implement and monitor procedures to maintain database integrity and ensure protocol compliance.
Collaborate with cross-functional teams to fulfill data requests from Clinical, Development, Marketing, and other departments.
Stay updated on industry trends, regulatory requirements, and clinical best practices; train staff on changes affecting clinical studies.
Support company initiatives including Quality Management Systems (QMS) and Environmental Management Systems (EMS).
Foster a safe, ethical, and professional work environment while modeling leadership and accountability.
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, with direct experience in clinical data management.
Advanced proficiency with databases, word-processing, graphics, and authoring software.
Strong leadership skills with the ability to set goals, provide constructive feedback, and develop high-performing teams.
Excellent verbal and written communication skills, capable of interacting effectively at multiple organizational levels.
Strong organizational, planning, and prioritization skills; ability to manage multiple tasks in a fast-paced, matrixed environment.
Preferred Qualifications:
Experience in enterprise or cross-division business unit models.
Compensation:
Base salary: $97,300 – $194,700 (location-dependent).
Why Abbott:
Abbott offers career development, comprehensive health and wellness benefits, tuition reimbursement, and an inclusive, globally recognized workplace. The company is committed to diversity, equity, and inclusion, providing a supportive environment for personal and professional growth.
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