Clinical Data Specialist
Medtronic is looking for a Clinical Data Specialist.
A Day in the Life
As a member of the Medtronic Core Clinical Solutions (MC2) Operations Support & Analytics Team, this position is responsible for CTMS data entry & data management activities which assure accuracy and quality of CTMS data.
- Owner of Master Data in Siebel CTMS, including Data Entry, data management, data cleaning, process improvements and process development.
- Supports and executes the development of processes and reports for the purposes, data quality and data review activities. Ability to read reports to advise on results.
- Proactive interaction with clinical study teams, globally IT and MC2 for data integrity issues and process improvement opportunities
- End user Siebel CTMS support for all CTMS roles, including training creation and delivery globally
- Support and/or work with project teams, disciplines, or functions within Medtronic as needed, including participation in CTMS CoE.
Supports all aspects of CTMS Data Management, including:
Data entry & maintenance of:
- master data (accounts, contacts, addresses)
- protocols, programs and product regions
- creation and advisement in templates, such as Monitoring Visit or Training Templates
- Data review and cleansing
- Creation and analyzing of reports, including the use of CDA, spotfire and excel
- End User troubleshooting and Training Support
- Assist in the RDC – CTMS interface data review and reconciliation
- Defining data requirements and processes to ensure delivery of highest quality of data
- Ensures timely and successful execution of the assigned data management tasks and tracking and reporting out metrics and key performance indicators
- Participates in project meetings to provide status updates to stakeholders. Provides communication of risk and mitigation for all data management related deliverables.
- Assists in overall project tasks such as process flowcharts, Standard Operating Procedures (SOPs), work instructions, training guidelines, etc.
- Supports the creation and maintenance of all essential CTMS data management documentation such as Data Entry Guidelines & Data Review Guidelines
- Remains current on CTMS system, processes, and best practices.Follows and implements CTMS data management standards and best practices and assures compliance to guidelines and work instructions/procedures.
Must Have: Minimum Requirements
- MBO or equivalent
- 3+ years’ experience in supporting Clinical Research or with Data Management /Siebel CTMS
Nice to Have
Expert Siebel CTMS systems knowledge of all roles
Big-picture and detail-oriented view of data management processes, tools and procedures.
Key Technical Competencies:
- Clinical database systems knowledge – understanding of data management processes, tools, and procedures.
- CDA Power User or Intermediate skills and knowledge in ad hoc data reporting, creating data review listings, metrics reporting.
- Effective written, verbal, and interpersonal communication skills.
- Effective organizational skills and high attention to detail.
- Ability to manage multiple priorities by applying time & task management approach.
- Track Time for specific tasks using the time tracking system
- Computer proficiency in MS Office products (eg, Microsoft Project, Excel, MS Word).
- Team player who effectively works with colleagues and business partners.
- Problem solving skills
- Ability to recognize and develop process improvements
- A good understanding of the clinical research life cycle process, knowledge in medical device and/or pharmaceutical data management environment.
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.
We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.
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.