Manager, Clinical Data Review

Job Summary

The Manager, Clinical Data Review role at Abbott is responsible for overseeing all data related to clinical studies. This includes managing a team, ensuring data integrity, and staying updated on regulatory requirements.

Responsibilities

• Hiring and retaining a diverse, highly qualified data management staff
• Providing career coaching, growth, and personal development
• Accountable for staff development: critiques, instructs, mentors, evaluates, and coaches
• Maintaining a safe work environment and a strong customer focus
• Managing data entry, data cleaning, data deliverables, and other data management activities
• Overseeing the development of CRFs, edit check specifications, and additional data collection requirements
• Managing Risk-Based Quality Management (RBQM) activities, including risk assessments, risk mitigation plans, data review strategies, centralized monitoring activities, and Key Risk Indicator (KRI) oversight
• Ensuring 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.)
• Maintaining knowledge of current and pending regulations through literature, trade journals, professional associations, and by attending conferences
• Supporting all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements
• Complying with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments

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
• Advanced computer skills in graphics, word-processing, databases, authoring programs, etc.
• Advanced personal computer skills (experience with Microsoft Office or equivalent required)
• Experience working in a broader enterprise/cross division business unit model preferred
• 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 in a highly matrixed and geographically diverse business 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