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This role is responsible for clinical data management (CDM) strategy, activities and operations for new and ongoing clinical research studies for the division. Has primary management responsibility directly or through subordinates for all data related to clinical studies. Responsible for the integrity of the processing and evaluation of clinical data. Identifies and implements the most effective, cost efficient and best business practices to execute processes and continually evaluates their effectiveness and appropriateness. Ensure that quality of services meets internal and external customer requirements and reports status to senior management. Responsible for identifying and implementing new, updated and/or enhanced systems for data collection for clinical studies.
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 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.
Leads a team of Clinical Data professionals to manage projects that require implementing new, updated and/or enhanced systems responsible for data collection for clinical studies.
Provides input and implements clinical data systems and data management processes.
Supports new and existing study database set-up; understanding of Case Report Form (CRF) design, edit check specifications and system components that relate to the design and integrity of the database for data collection of a study. Oversees the development of CRFs, edit check specifications, and additional data collection requirements required for tracking and analysis. Experience with Software Development Lifecycle (SDLC).
Manages the process of user requirement analysis and user acceptance testing from the creation of test scripts through execution; including providing any related findings that are applicable throughout the testing phase.
Manages processes to ensure data integrity leveraging 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 query requests and reporting from clinical databases, Oversees the process and provides other departments with queries 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. Seeks continuous improvement by engaging expertise across the organization and through external professional organizations.
Work with vendors to assess new technologies and help to drive and align the implementation. Ensure that the installed solution satisfies defined performance, security and availability requirements by acting as a liaison with the vendor.
Leads development and quality control (QC) of data management documents including data management plans, data review guidelines, database validation protocols, and departmental standard operating procedures (SOPs).
Ensures compliance 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.
Other miscellaneous duties as may be required.
Required Education and Experience:
Bachelor of Science in related field is required.
SCDM certification would be considered an asset.
In vitro diagnostics/medical device company experience or relevant systems experience in a clinic/hospital/university environment is preferred. A minimum of four plus years of demonstrated experience at a supervisory/managerial level preferred.
Advanced personal computer skills (experience with Microsoft Office or equivalent required) in graphics, word-processing, databases, authoring programs, etc.
Software and Systems/Hardware experience with good understanding of key industry leading software platforms (Microsoft, R, SAS, etc.) including some level of certification desired.
Knowledge and experience building/customizing Clinical Trial Management Software Applications.
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.
Ability to travel approximately 5%.
Abbott Canada is committed to the hiring, advancement and fair treatment of individuals without discrimination based on factors such as race, sex, colour, ethnic or national origin, religion, disability, age, citizenship, family or marital status, political beliefs, sexual preference or other factors included in human rights legislation.
Our diversity goals for recruitment, hiring, and retention are embedded in our corporate goals, and our diversity initiatives are supported by the highest level of the organization.
We strongly believe that a diverse workforce fosters more creative and innovative thinking throughout the organization. Creating an inclusive environment, where everyone is respected and valued, enables us to leverage our diversity as a business driver and strengthens our position as a global leader.
Abbott strives to promote and maintain an inclusive, high-performing culture that allows all employees to reach their full potential and contribute to Abbott’s success.
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