Job Title: Manager, Clinical Data Review – Medical Devices (On-site)
Locations:
Maple Grove, Minnesota, USA
Sylmar, California, USA
Category: Medical and Clinical Affairs
Company: Abbott
About Abbott
Abbott is a global healthcare leader dedicated to helping people live more fully at all stages of life. Its diverse portfolio includes diagnostics, medical devices, nutritionals, and branded generic medicines. With over 114,000 employees in 160+ countries, Abbott consistently ranks among the world’s most admired companies and best workplaces for diversity, working mothers, female executives, and scientists.
About Abbott Medical Devices
Abbott’s medical device divisions develop innovative, minimally invasive technologies that improve patient outcomes and quality of life.
Examples of key technologies:
Continuous glucose monitoring systems
Cardiac therapies for heart disease
Devices supporting chronic pain and movement disorders
Every day, Abbott’s devices:
Help 10,000+ people achieve healthier hearts
Improve life quality for thousands living with chronic pain
Free 500,000+ people with diabetes from routine fingersticks
Position Summary
The Manager, Clinical Data Review will lead a team responsible for clinical data management activities across medical device studies.
This role includes accountability for:
Data entry activities
Case Report Form (CRF) design
Edit check specifications
Clinical database development, cleaning, and analysis support
The manager ensures data integrity, regulatory compliance, and operational efficiency while mentoring staff and collaborating across departments.
Key Responsibilities
Leadership & Team Management
Hire, mentor, and retain a diverse, highly qualified data management team.
Provide career coaching, performance feedback, and development opportunities.
Ensure staff are trained in data management procedures and compliance standards.
Manage the work output of subordinates and subcontractors.
Foster a safe, ethical, and customer-focused work environment aligned with Abbott’s guiding principles.
Clinical Data Operations
Oversee data entry, data cleaning, validation, and deliverables for clinical trials.
Manage the design and development of CRFs and edit check specifications.
Ensure data integrity through:
Protocol compliance tracking
Query management for missing or discrepant data
Data outlier evaluation and quality checks
Provide datasets and custom reports from clinical databases (e.g., Oracle Clinical).
Support other departments (Development, Marketing, etc.) with data outputs.
Regulatory & Quality Compliance
Stay current on industry regulations and emerging data standards.
Train team members on changing regulatory requirements impacting clinical trials.
Comply with FDA, QMS, and EMS guidelines.
Support all company initiatives related to quality management systems.
Maintain positive and collaborative relationships across internal teams and vendors.
Required Qualifications
Education: Bachelor’s degree in a science-related field (or equivalent combination of education and experience).
Experience: Minimum 8 years of progressively responsible experience in the pharmaceutical, biotechnology, or medical device industry.
Proven ability to conduct needs assessments, develop market-related data, and manage end-to-end data operations.
Technical Skills: Advanced proficiency in databases, word processing, graphics, and authoring programs.
Leadership Skills:
Goal setting and performance management
Constructive feedback and relationship building
Team leadership in a fast-paced, matrixed organization
Excellent verbal and written communication at multiple organizational levels.
Strong organizational and planning skills with the ability to prioritize and meet deadlines.
Preferred Qualifications
Experience working in a cross-division or enterprise-level business model.
Familiarity with Oracle Clinical or similar data management systems.
Compensation
💰 Base Pay Range: $97,300 – $194,700 per year
(Pay range may vary by location.)
Employee Benefits
Free medical coverage under Abbott’s Health Investment Plan (HIP) PPO.
High employer contribution retirement savings plan.
Tuition reimbursement and Freedom 2 Save student debt program.
FreeU education benefit — a low-cost path to a bachelor’s degree.
Recognized as a top workplace for diversity, inclusion, and career growth.
Additional Information
🌐 Apply Online: www.abbott.com
💡 Benefits Info: www.abbottbenefits.com
📱 Connect with Abbott:
Facebook: facebook.com/Abbott
Twitter: @AbbottNews | @AbbottGlobal
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