Clinical Data Systems Analyst II - Maple Grove, United States - Abbott Laboratories

Description

Abbott is a global healthcare leader that helps people live more fully at all stages of life.

Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines.

Our 114,000 colleagues serve people in more than 160 countries.


ABOUT ABBOTT DIAGNOSTICS
The key to successful treatment and full recovery is often fast, accurate diagnosis.

Abbott's life-changing tests and diagnostic tools provide insights that enable smarter, faster decisions and transform the way the world is managing health.

Our pioneering technology spans the world of healthcare operations - with medical diagnostic instruments, tests, automation, and informatics solutions for hospitals, reference labs, blood centers, emergency departments, physician offices, and clinics.

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life.

You'll also have access to:

• Career development with an international company where you can grow the career you dream of.
• Free medical coverage for employees via the Health Investment Plan (HIP) PPO
• An excellent retirement savings plan with high employer contribution
• Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor's degree.
• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.

The Opportunity

Our Diagnostics business currently has an opportunity for the role of Clinical Data Systems Analyst II for our Maple Grove, MN location.

The primary function of this position is to be responsible for various special projects related to the data systems aspects of the clinical studies conducted.

These special projects will include implementing new, updated and/or enhanced systems that are responsible for data collection for clinical studies as well as providing assistance to multiple customers globally, externally and internally.

Ensuring the integrity of the processing and evaluation of clinical data, analyst closely collaborates with the Clinical Affairs Organization, Data Management and Systems Development groups within the Clinical Data Operations organization.

Participates in the collection of project requirements analyzing business needs.

Identifies and routinely uses the most effective, cost efficient and best business practices to execute processes; continually evaluates their effectiveness and appropriateness.

Exercises judgment in proactive planning, organizing and performing work; monitors performance and effectively communicates status within area of responsibility. Assures that quality of services meets internal and external customer requirements. May serve as a project manager in various projects.

What You'll Work On

• Proficient understanding of Clinical Trial Management Process and regulations that apply, engages professional association, seeks continuing education about company devices and therapies.
• With general supervision, manages projects that will require implementing new, updated and/or enhanced systems responsible for data collection for clinical studies as well as assistance with multiple customers globally, collaborating within Global Clinical Affairs as well as with other external and internal customers.
• May assist leadership with project prioritization and development of clinical technology strategy, and communicate when deadline is not able to be met and solution on steps going forward.
• Proficient ability to troubleshoot process-related items and the direct affects that it has on the applicable systems; applies out-of-the-box thinking to solve application and/or report requests from customers and Clinical Data Systems.
• Actively supports and applies best practices and established standards; ability to utilized project management skills to work with multiple projects through communication, leading meetings and maintain any notes and meeting deadlines that are required.
• Actively supports, leads and collaborates with other team members to complete projects. Performs as liaison between internal and external customers and the clinical data systems software engineers. Practices effective communication, active listening and team work.
• Proficient ability to analyze user requirements, procedures, and problems and to gather, organize, write and produce project requirements and specifications documentation that clearly states what is needed for the application; including leading meetings/discussion with direct manager regarding systems and/or processes, take meeting minutes and providing communication regarding the progress of project.
• Proficient ability to understand and perform user acceptance testing from the creation of test scripts through execution; includes providing any related findings that are applicable throughout the testing phase.
• Proficient contribute in writing technical documentation and manuals. Proficient ability to communicate customer-requested changes to the developer regarding the system, as well as communicate any issues with development to the system directly to the external and/or internal customers.
• Ability to discuss all assigned projects with general supervision and be able to answer any detailed question regarding the project impacts on other systems.
• Proficient ability to communicates well with all levels of employees including peers, study teams and management to support studies and goals.
• Proficient experience in training to various sized audiences on applications and/or reports including training set-up, training documentation, live training, training recordings, utilizing training tools including PowerPoint.
• Will be Subject Matter Expert (SME) in one or more applications.
• Proficient ability to communicate technical items to non-technical audiences.
• Proficient experience with Software Development Lifecycle (SDLC). Follows and provides input to Departmental Standard Operating Procedures (SOPs), Departmental Work Instruction (DWIs), and guidelines.
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Proficient knowledge and complies with Good Clinical Practices (GCP), US Food and Drug Administration (FDA) regulations, International Conference on Harmonization (ICH), ISO 14155, other regulatory requirements, applicable company policies, operating procures and processes.
• Performs other related duties and responsibilities, on occasion, as assigned.

EDUCATION AND EXPERIENCE YOU'LL BRING
Minimum Qualifications

• Bachelor's Degree in Computer Science, Health Sciences or related field OR an equivalent combination of education or work experience.
• Minimum 3 years working in a clinical research environment and/or healthcare industry experience.
• Organizational and proficient project management skills, as well as attention to detail.
• Highly skilled with Microsoft office products including Word, Excel, and Access.
• Proficient ability to work with database management systems.
• Proficient knowledge of database terminology and technology.
• Preferred knowledge of Relational Databases and demonstrated ability to generate queries using Query languages like Structured Query Language (SQL).
• Proficient knowledge and experience in supporting the building of clinical trial databases using Oracle. Clinical or equivalent.
• Proficient knowledge and experience building/customizing Clinical Trial Management Software Applications.
• Ability to work in a highly matrixed and geographically diverse business environment.
• Proficient ability to work within a team and as an individual contributor in a fast-paced, changing environment.
• Strong oral and written communication skills.
• Ability to meet deadlines and handle multiple assignments in a timely manner and meet assigned deadlines.
• Basic understanding of human physiology or any prior involvement with medical field.

Preferred Qualifications

• Program Management Professional (PMP) certification is desired.
• Basic understanding of Agile methodologies.

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life.

Abbott is an Equal Opportunity Employer, committed to employee diversity.

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The base pay for this position is $57, $114, In specific locations, the pay range may vary from the range posted.