Senior Clinical Interface Specialist, Medtronic Core Clinical Solutions
Santa Rosa South, California
Permanent (Full time)
Senior Clinical Interface Specialist, Medtronic Core Clinical Solutions
Oct 01, 2021
Careers That Change Lives
In this role as a Senior Clinical Interface Specialist in MC2 Solutions Development, your will pay a lead role in all aspects of initial configuration and maintenance for the interface layer between our primary data collection tools (Oracle Clinical and RAVE) and our clinical trial management (Siebel CTMS) system. You will be at the core of all set-up discussions, engaging all stakeholders (Data management, Clinical Payments, Clinical Contracts, Study teams), coordinating the process of contract review and revisions, with the target of optimizing configuration feasibility and operational efficiency, and manage project/process timelines for all interfaces builds and updates.
As part of Clinical Research, Medical Science, and Regulatory Affairs (CMRA), our organization strives to be a driving force behind Medtronics strategies to improve health and patient experience through expert leadership, execution, and innovation.
Medtronic Core Clinical Solutions (MC2) function supports clinical studies from all Medtronic Operating Units globally, offering to our internal partners services that span across all stages of clinical trials operation, from designing and building data collection systems to partnering with statisticians in conducting analyses, through conducting monitoring activities at the hospitals, tracking adverse events and ensuring regulatory requirements on safety reporting are met.
Within MC2, Global Clinical Data Solutions (GCDS) offers Data Management, Solutions Development, Statistics, and Statistical Programming services to our partners. We support the design and build of data collection systems, integrations, and data interchange between corporate systems, and reporting/dashboarding solutions. We offer statistical design services, and statistical analysis provide technical support and business analysis expertise in the technology and IT domain to other MC2 functions and Medtronic stakeholders.
Join a diverse team of innovators who bring their worldview, their unique backgrounds, and their individual life experiences to work every day. Its no accident we work hard to cultivate a workforce that reflects our patients and partners. We believe its the only way to drive healthcare forward and remain a global leader in medical technology and solutions.... open for remote with the . or within commuting range to any eligible Medtronic facility (., Mounds View, MN / Santa Rosa, CA / Memphis, TN)
Ability to travel up to 15%, Domestic and International
A Day in the Life
Responsibilities may include the following and other duties may be assigned.
The Senior Clinical Interface Specialist is responsible for applying Clinical Process and Clinical Systems expertise to the definition and configuration of interfaces between clinical systems, primarily data collection tools / EDC systems (OC, RAVE) and Trial Management Systems (CTMS), as needed to support clinical trials. In this setting, she/he:
- Plays a lead role in all aspects of EDC-CTMS interface set-up and maintenance for each study in her/his portfolio. In particular
- Manages interface implementation project timelines for all interfaces builds and updates
- Coordinates and engages all stakeholders (Data Management, Payments, Contracts, Study Management) in the process of contract template and contracts review and revisions, maintaining proactive communication for all tasks related to review, build, test, release and any updates
- Reviews Case Report Forms (CRFs) and clinical contracts, providing feedback and informal approvals for both
- Creates documentation related to EDC-CTMS initial configuration and updates (PPCs) as required per SOPs
- Configures the EDC-CTMS interfaces
- Coordinates Testing and Release of EDC-CTMS interfaces
- Partners with central CTMS teams in IT and MC2 as needed (., troubleshooting any issues in CTMS, addressing study-specific needs and requests, evaluating system improvement suggestions, etc.)
- Provide support to IT CTMS team in testing for new releases of CTMS interface code
- Participates with her/his peers in the Interface Specialists team to continuously innovate, improve processes, build and/or improve work-aids, define and/or revise best practices.
Must Have (Minimum Requirements):
To be considered for this role, the minimum requirements must be evident on your resume.
- Bachelors degree required with a minimum of 4 years experience as an Analyst or Systems Analyst/Specialist or advanced degree with a minimum of 2 years experience as an Analyst or Systems Analyst/Specialist
Nice to Have (Preferred Qualifications):
- Experience defining and/or interpreting requirements for technical systems/solutions through understanding data relationships between systems and applying business logic to achieve desired outcome (., payment indicators)
- Business system analysis at Medtronic
- Experience in EDC systems, Siebel CTMS and/or clinical systems, systems development life cycle
- Experience in CH/GCP/FDA regulations and guidelines as they pertain to clinical systems including 21 CRF Part 11
- Experience in Clinical Study Processes
- Experience in Clinical processes, particularly of contractual/compensation aspects
- Experience in relational databases and data processing, with previous experience with basic querying using SQL language
- Client and customer focus in all aspects
- Excellent time management, organizational skills, attention to detail and oral/written communication skills
- Critical thinking and creative problem solving
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. Lets work together to address universal healthcare needs and improve patients lives. Help us shape the future.
Physical Job Requirements
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
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. For Office Roles: 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. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America).
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
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It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.