Senior Clinical Data Manager (Remote) (R443768)
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. 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
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.
- Self-directed initiators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.
- Collaborative partners. People who build and leverage cross-functional relationships to bring ideas, data and insights to drive continuous improvement in functions.
- Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
What you will do
As The Senior Clinical Data Manager you will manage data management activities to support the clinical study team in support of multi-center spine clinical trials. With project level responsibilities including managing the development, implementation, maintenance, and storage of clinical study data to include by not limited to data process, data review, database development, query management, data quality control, database lock, results, posting, and auditing. The Senior Clinical Data Manager is also responsible for the oversight of the CROs providing data management, statistical and core laboratory (i.e., radiographic) support, as it relates to the overall clinical program. This role will ensure compliance to FDA guidelines, Good Clinical Data Management Practices, and departmental SOPs, and all other applicable regulations. You will provide greater support to the group by taking on projects of greater complexity under limited supervision.
Responsibilities may include but are not limited to:
- Main point of contact for data management related services when working with vendors (database developer, independent radiologists, etc.);
- Coordinate all data management start-up activities including the development and maintenance of:
- CRFs/eCRFs/CRF specifications
- Edit check specifications
- Data Management Plan (DMP) and related Data Management Files (DMF)
- Coordinate and perform testing of database systems, including initial user acceptance testing (UAT) of CRFs/Edit check/data outputs and UAR of Change Orders throughout the course of a study Oversee the building, testing, data clean-up, and validation of clinical the database
- Manage and prioritize project deliverables per study timelines and communicate with the Clinical Study Manager (CSM) throughout the course of the study
- Collaborate with Clinical Project/Study Managers to create reports in order to facilitate management of clinical protocols.
- Perform comprehensive hands-on data review of all CRF data through data review, query management and manual review
- Analyzes study data metrics to assess data quality and track/manage study progress related to data management functions
- Coordinate data entry quality control, create worksheets, review findings, calculate error rates and approve quality control report for clinical studies
- Oversee diagnostic image handling and review process and ensure quality of process
- Ensure documentation and management of the clinical study data is in accordance with regulations, GCDMP and Stryker SOPs
- Participate in reviewing and responding to QA audit report
- Manage the locking process of the study database and sign off approval
- Read and understand study SAS listing and summary reports
- Assist with data preparation for reporting clinical data results for clinicaltrials.gov posting, regulatory submission, publication and presentations
- Participate in preparation and presentation of data management activities and new initiatives
- Participate in continuous (breakthrough) improvement activity and process re-engineering projects in support of Stryker Spine Business Process Excellence initiatives
- Development, publication, and continuous improvement of metrics for data management.
- Communicate progress to the project study teams on an ongoing basis.
- Work with marketing, clinical and regulatory groups to support statistical analysis of trial data, regulatory submissions and scientific papers. This includes:
- Clean-up clinical data from all ongoing clinical studies
- Review of interim/final reports
- Extract data sets and analyze, as appropriate, data for presentation and publication requests
- Take a major role in managing the data management budget as well as preparing input during the yearly budget development process.
What you need
Bachelor’s degree required; Focus in science or health-related field such as Life Sciences, Biology, Chemistry, Medical Science, Biomechanics, Biomedical Sciences, Nursing, or General Science preferred
- Minimum of 5 years of experience in data management or related industry experience required.
- Attention to detail, as well as organizational, communication, and time management skills.
- Knowledge and ability to use computer systems and desktop applications; proficiency in Visual Basic computer programming, SAS, Adobe software, Excel, PowerPoint, Word, as well as other desktop applications, programming methodologies and languages preferred.
- Knowledge of:
- Database Management systems.
- Drug and/or Device Study Development Processes.
- IDE requirements and/or GCP.
- ICH, GCP and 21 CFR Part 11 guidelines.
Know someone at Stryker?
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