Medtronic is an Equal Opportunity/Affirmative Action Employer
As a member of Medtronic Clinical Research Institute (MCRI) Data Management, this position is responsible for management of data and assuring quality of data delivery.
This position drives the development of data management tools and data quality and review activities.
This position will have interaction with clinical study teams, clinical operations teams, and Global IT.
This position provides subject matter expertise for all data management related activities for the clinical teams and for more junior members of the Data Management organization.
Initiate, plan, execute and manage all aspects of data management from case report form development to the final database lock. This includes case report form design and development, database/edit check specification requirements definition, user acceptance testing, creation and maintenance of the data management plan and the data quality plan.
Creates and ensures the successful execution of data management elements of project plan. This includes monitoring tasks and managing timelines related to data management deliverables, database development and database snapshot & lock.
May define data review requirements and processes to ensure delivery of the highest quality of data.
Performs or oversees data review as identified in the data review requirements for projects of varying complexity. Analyzes the interrelationships of data and defines logical aspects of data sets to reduce errors and queries.
Collaborates with the database developers on the design, documentation, testing and implementation of study database based on data management and protocol requirements.
Plan, execute and manage multiple projects of moderate complexity; utilizing project management tools and techniques.
Develops and utilizes reports to track study progress and ensure timelines and quality expectations are met.
Identify risks & mitigation actions for data management related deliverables.
Manage internal and external partnerships through execution and ensure accountability to results and deliverables.
Lead and support training initiatives and develop training materials.
Maintain a broad understanding of current processes and methods as well as trends and directions of the Clinical Data Management industry.
Often serves as data management subject matter expert to other project teams and mentors other employees within the organization.
Applies technical expertise and develops solutions to complex problems that require the regular use of ingenuity and creativity.
Participates in defining data management standards, best practices and Standard Operating Procedures compliance.
YEARS OF EXPERIENCE:
4 years experience in clincial research, IT, or working with data in a healthcare setting, or Master’s degree with 2 years experience.
Knowledge of clinical research, Good Data Management Practices and Good Clinical Practices, Food and Drug Administration 21 CFR Part 11 regulation, and Health Insurance Portability and Accountability Act.
Data management experience in medical device and/or pharmaceutical industry
Ability to use judgment to effectively solve problems
Able to perform routine data management tasks with minimal supervision; receives instruction on new projects.
Excellent oral and written communication skills with the ability to communicate to a large or small group.
Proven track record of prioritizing tasks and manage competing priorities based on project plan expectations
Ability to create data management project plan and drive on-time completion of project plan deliverables
Experience mentoring and setting priorities for junior team members
Experience using Microsoft Office products
High degree of initiative and self-motivation with a strong sense of accountability
Experience working in clinical data management applications (e.g. Oracle Clinical) and report tools
Demonstrated abilities to develop and execute continuous improvement projects
Strong interpersonal and influence management skills
Proven leadership skills and business acumen
Physical Job Requirements
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers.
Medtronic - 12 months ago
Medtronic, Inc. is engaged in medical technology. The Company functions in seven operating segments that manufacture and sell device-based...