Job Details

Stryker

http://www.stryker.com

Senior Clinical Data Specialist (Remote)

Occupation: Equipment/Technology Specialist

Specialty: Equipment and Facilities Specialist

Visa sponsorship provided: No

Location: Leesburg, Virginia, United States

Why join Stryker?

We are proud to be named one of the World’s Best Workplaces and a Best Workplace for Diversity by Fortune Magazine! Learn more about our award-winning organization by visiting stryker.com

Our benefits include bonuses; commissions; healthcare; insurance benefits; retirement programs; stock based plans; paid time off plans; family and parenting leaves; tuition reimbursement; wellness programs; onsite fitness centers and cafeterias; discount purchase programs; and service and performance awards – not to mention various social and recreational activities.

Stryker is seeking to hire a Clinical Data Specialist to join our Spine Division. This role will based remotely anywhere in the United States.

As the Clinical Data Specialist, you will improve database quality in clinical trials. You will be responsible for ensuring all data-related operational aspects of studies are being conducted with compliance to regulatory guidelines, policies, and procedures while ensuring the data has the highest possible level of research study data integrity. You will coordinate data from different sources, including oversight of the vendors/contractors providing data management, statistical and core laboratory support, as it relates to the overall clinical programs.

Why come to Stryker? Dozens of Reasons To Love Stryker

WHO WE WANT:

• Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes – finding ways to simplify, standardize and automate. 

 • Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues. 

 • Self-directed innovators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.

WHAT YOU WILL DO

Responsible for reviewing data for assigned clinical projects. Identify data trends on a project level.
Develop and/or maintain data management plans, Case Report Forms, Database Specifications/Edit Check Specifications,
Develop complex status reports, specifications for analysis of clinical trial data for interim and final reports, training materials, and other study plans/guidelines. Determine corrective or follow-up action plans as necessary.
Begin to identify appropriate standard query/Data Clarification Form (DCF) text. Integrate or close queries/DCFs for all categories on a project or program. Perform quality control of queries/DCFs for rest of team.
Build, test, and validate the programming of electronic data capture (EDC) systems, including design and oversee UAT for studies. Ensure databases are in accordance with internal and external established clinical trial and regulatory standards, and local procedures.
Coordinate the Data Entry Verification Assessment (DEVA) process for a specific study. Begin to identify areas of process improvement based upon DEVA results.
Train internal and external collaborators in study specific clinical data management processes, the CRF, EDC system, and completion guidelines.
Management, tracking and resolution of issues noted by system users, including those requiring submission to system vendors and report development. Troubleshoot data flow and data processing issues.
Assist in the development, reporting, and continuous improvement of metrics for data management.

WHAT YOU NEED

Bachelor’s degree required.
Minimum of 2 years of experience in clinical research data management or related industry experience required.
Knowledge with imaging systems, electronic data capture (EDC), and database management systems and ability with programming languages including the creation of data entry, query processes, data clarification form (DCF) generation, and data quality checks.
Knowledge of:

- Drug and/or Device Study Development Processes.

- Current Industry Standards, such as, but not limited to: ICH GCP, ISO14155, Good Data Management Practices, IDE requirements, HIPAA, GDPR guidelines, and 21 CFR Part 11 guidelines.

$71,600 - 149,300 salary plus bonus eligible + Benefits (Health, Vision, Dental, 401K, Tuition Reimbursement, Employee Assistance Program, Wellbeing Program, Employee Stock Purchase Program). This information reflects the anticipated salary range for this position based on current national data. Actual minimum and maximum may vary based on location. Individual pay is based on skills, experience, and other relevant factors.

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About Stryker

Stryker is one of the world’s leading medical technology companies and, together with our customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes.