Stryker is one of the world’s 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 Manager, Data Management to join our Neurovascular Division to be based in Fremont, CA or remotely anywhere in United States.
Stryker’s 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. In February 2019, Stryker Corporation (NYSE:SYK) announced that for the ninth consecutive year has been named as one of the FORTUNE 100 Best Companies to Work For ranking 11 out of 100. If you join our organization; will be working to “Make Stroke History”. 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: [ Link removed ] - Click here to apply to Manager, Data Management.
Who we want
Effective communicators. People who can interpret information clearly and accurately to concisely communicate results and recommendations to stakeholders, senior management, and their teams.
Talent developers. Growth-oriented managers who recruit and hire top-performing talent and prioritize the development of their team members.
Managers who drive performance. People who implement process improvements and leverage the talent of their team to consistently increase performance and productivity.
Data managers. People who enjoy compiling, organizing and consolidating large volumes of data and reports.
Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.
What you will do
As the Manager, Data Management you will be responsible for guiding and managing all clinical data management activities according to quality standards, ICH guidelines, GCP and regulatory requirements. The person, reporting to the Head of Biometrics, is also responsible for managing the data management team to ensure the staffing and the operational aspects of the data management group are in line with the company’s clinical programs.
- Manage the Data Management resources.
- Represent clinical data management in meetings with internal cross-functional teams, external vendors and regulatory agencies.
- Oversee and participate in all data management activities for multiple clinical development programs, such as vendor evaluation, CRF development, database specifications, user acceptance testing, query resolution, data review and data base lock.
- Collaborate with cross-functional individuals from Clinical Operations, Clinical Development, Medical Affairs, Regulatory, Project Management, and CMC in support of project deliverables and regulatory needs.
- Represent SNV in the selection and implementation of corporate clinical systems.
- Create thorough data quality checks and data review strategies to ensure the integrity of the clinical data.
- Monitor regulatory initiatives (US and international) that impact data managements and implement appropriate changes to the groups’ practices to ensure regulatory compliance.
- Manage the overall effort of the Clinical Data Management group to ensure quality clinical trials.
- Participate in the data preparation for Regulatory submissions.
- Recruit and train high performing data management staff.
What you need
- A minimum of a Bachelor’s Degree required; emphasis in Health Sciences, Statistics, MIS or Computer Science discipline preferred.
- A Masters of Science or a MBA preferred.
- A minimum of 8 years in a combination of Clinical Research and/or Clinical Data Management experience required.
- A minimum of 6 Clinical Data Management experience required.
- Previous management experience preferred.
- Strong expertise in electronic data capture systems is required.
- Knowledge of various CDISC models (CDASH, STDM) and experience transforming raw data into those standards preferred.
- Complex and/or international trials experience preferred.
- Previous 510(k), PMA, NDA, or BLA experience is preferred.
Work From Home: Occasional
Travel Percentage: Up to 25%
Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.
Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.
Good Clinical Practices (Gcp)
Clinical Data Management
Non Disclosure Agreement (Intellectual Property Law)
Electronic Data Capture