JOB DESCRIPTION:The Opportunity 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. Additionally, will identify and routinely use the most effective, cost efficient and best business practice to execute processes; continually evaluate their effectiveness and appropriateness. The Manager, Clinical Data Review will exercise judgment in planning, organizing and performing work; monitor performance and report statuses to executive management as well as assures that quality of services meets internal and external customer requirements. The individual will remain current on developments in field(s) of expertise to ensure that clinical trial protocol elements are appropriately captured on CRFs and databases for analysis; responsible for ensuring database integrity.
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.
Required 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; 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.
Preferred Qualifications - Experience working in a broader enterprise/cross division business unit model
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life.
The base pay for this position is $114,000.00 - $228,000.00
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:Clinical Affairs / Statistics
DIVISION:MD Medical Devices
LOCATION:United States > Sylmar : 15900 Valley View Court
ADDITIONAL LOCATIONS:United States > Maple Grove : 6820 Wedgwood Road N.
WORK SHIFT:Standard
TRAVEL:Yes, 10 % of the Time
MEDICAL SURVEILLANCE:No
SIGNIFICANT WORK ACTIVITIES:Awkward/forceful/repetitive (arms above shoulder, bent wrists), Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
