Manager, Clinical Data Review – Medical Devices (on-site)
Abbott
Summary
We are looking for our next Manager, Clinical Data Review to lead our team on-site out of our Sylmar, CA location. 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.
Job description
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 SJM 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 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.).
- Manages custom requests and reporting from clinical databases (i.e., Oracle Clinical, etc.) made by the Clinical department and other departments.
- Provides other departments with outputs from clinical databases as necessary (e.g., Development, Marketing, etc.).
- 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.
Requirements
- 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.
- 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
Benefits
- Medical coverage
- Retirement savings plan
- Tuition reimbursement
- Student debt program
- Education benefit
- Career development
Company overview
Abbott Laboratories is a global healthcare leader with a 135-year legacy of innovation, dedicated to helping people live healthier, fuller lives through life-changing technologies and products. Headquartered in Abbott Park, Illinois, the company operates in more than 160 countries with a workforce of approximately 114,000 professionals. Abbott's diversified portfolio spans four core business segments: medical devices, diagnostics, nutrition products, and branded generic pharmaceuticals. The company is particularly renowned for its groundbreaking medical devices including cardiovascular technologies, diabetes management systems like the FreeStyle Libre continuous glucose monitor, neuromodulation devices for chronic pain, and the AVEIR DR dual chamber leadless pacemaker system. In diagnostics, Abbott has been instrumental in developing critical tests, including the first licensed HIV test in 1985 that helped secure blood supply safety. The company's nutrition division produces leading infant formulas like Similac, while its pharmaceutical business provides quality branded generic medicines. Abbott consistently ranks among Fortune's Most Admired Companies and maintains a strong commitment to sustainability and corporate responsibility, making it a trusted partner in advancing global healthcare.