Job Description

Stryker is one of the worlds leading medical technology companies and is dedicated to helping healthcare professionals perform their jobs more efficiently while enhancing patient care. The Company offers a diverse array of innovative medical technologies, including reconstructive, medical and surgical, and neurotechnology and spine products to help people lead more active and more satisfying lives. We are currently seeking a Senior Clinical Data Specialist to join our Neurovascular Division to be based in Fremont, CA.

Strykers Neurovascular division is focused on advancing the practice of less invasive stroke therapies through its Complete Stroke Care solutions. The business is dedicated to providing innovative stroke products and services for ischemic and hemorrhagic stroke and committed to providing clinical education and support to help physicians deliver better patient outcomes. Products include: stent retrievers, detachable coils, stents, balloons, guidewires and microcatheters. Stroke is devastating; 1 of 20 deaths is from a stroke, according to the CDC. Watch this video to see how Stryker is making a difference: https://www.youtube.com/watch?v=JANFZrpt1Hg.

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.

* Data managers. People who enjoy compiling, organizing and consolidating large volumes of data and reports.

* 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 together ideas, data and insights to drive continuous improvement in functions.

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

What you will do

As the Senior Clinical Data Specialist, you will perform and provide oversight of data management study activities and timelines from study startup through study close-out. You will also contribute to process improvements and key initiatives within the department.

* Complete study startup activities such as CRF (Case Report Form) design, Database Specifications, and Edit Check Specifications.

* Work with various vendors/CROs to obtain expected deliverables in a timely manner.

* Sit on Clinical Core Teams and actively participate in team meetings.

* Review and provide feedback on Clinical core team documents.

* Lead or participate in Electronic Data Capture (EDC) User Acceptance testing (UAT) and EDC Go-Live.

* Write or review Data Management Plans (DMP) for specific projects or programs.

* Write or review Data Review Guidelines (DRG) for specific projects or programs.

* Write or review CRF Completion Guidelines (CCGs) for specific projects or programs.

* Develop complex status reports and utilize status reports to determine follow-up action.

* Train Investigators and Coordinators at Investigator Meeting in the CRF, the EDC system, and the completion guidelines.

* Review data and identify data trends on a project level.

* Integrate or close queries/DCFs for all categories on a project or program.

* Write or review study specific coding guidelines.

* Code verbatim terms & perform consistency review of coded terms.

* Collaborate with Medical Sciences for coding review and approval.

* Perform database snapshot/lock activities and final database decommission.

* Extract and transfer study data to Biostatistics.

* File and archive all study-level data management documentation as appropriate.

* Provide input into clinical data management training curriculum.

* Train the CDM and/or Clinical Core Team in the study specific clinical data management processes.

* Write or review draft of new/revised data management WI/SOP.

* Identify processes for improvement related to department process.

* Train and mentor junior staff within department.

* Ensure up to date training.

What you need

* A Bachelors Degree required; preferably in Health Sciences or related discipline.

* A Masters or MBA preferred.

* A minimum of 4 years of clinical data management experience required; experience within a Sponsor Medical Device organization highly desired.

* Detail-oriented with excellent interpersonal skills.

* Strong vendor/CRO oversight experience highly desired.

* Electronic Data Capture (EDC) experience required; Medidata RAVE preferred.

* Report-writing and Core Lab experience highly desired.

* Previous 510(k), PMA, NDA, or BLA experience is preferred.