Stryker
Location
Fremont, CA | United States
Job description
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
Stryker is currently seeking a Senior Clinical Program Manager to join our Neurovascular division. This is a hybrid role based in Fremont, CA.
Who we want:
Talent developers. Growth-oriented managers who recruit and hire top-performing talent and prioritize the development of their team members.
Compliance-focused orchestrators. Managers who carefully oversee people, processes, and deliverables to ensure compliance with company policies and procedures
Managers who drive performance. People who implement process improvements and leverage the talent of their team to consistently increase performance and productivity.
What you will do
As the Senior Clinical Program Manager , you will lead the design and execution of multiple high quality clinical studies to ensure safety and effectiveness of Stryker products. You will execute large scale, complex clinical programs for assigned therapeutic areas, managing clinical project team members to appropriate and timely completion of projects.
Responsible and accountable for several concurrent global clinical studies as part of a therapeutic program product strategy.
Leverages resources, expertise, and knowledge across multiple projects to ensure attainment of project deliverables.
Hires, trains, develops, mentors, and supervises Clinical Project Managers and other clinical staff. Develops staffing plans for therapeutic area or region.
Participates in the development of global clinical strategies for assigned therapeutic area(s) in collaboration with Regulatory Affairs, Marketing, Research & Development, Reimbursement and Outcomes planning, and regions to obtain approvals by the most effective method possible.
Supports regulatory/clinical strategies as the clinical representative for the therapeutic area or region.
Oversees therapeutic area budget and resources; ensures project managers prepare and manage budgets for projects.
Oversees development and/or provides input to study protocols and associated clinical study documentation drafted by Clinical Project Manager and other clinical team members (e.g., Site Selection, CRFs, Investigational Device forecasts, Monitoring Plan, DMC and CEC Charters, etc.)
Ensures the design, set up and execution of investigator and coordinator meetings is completed by the project manager; represents the therapeutic area and interfaces with Key Opinion Leaders.
Provides oversight of individual clinical trials to ensure that safety concerns and/or adverse events are identified and appropriate responses to such concerns are developed and executed.
Provides advice on the reportability of adverse events and other clinical trial issues to regulatory agencies.
Manages data release and review meetings for projects in therapeutic area; reviews and participates in finalizing and approving final manuscript or final reports for projects.
Participates in the dissemination of clinical information to the clinical team members and extended core team members, as appropriate.
Represent Clinical Affairs on Product Development team as needed.
Reviews and approves corrective action plans at individual sites and across study as prepared by project manager. Expected to participate in internal/external study-related audits as the subject matter expert for therapeutic area.
Demonstrates thorough knowledge of and coaches others in the appropriate application of clinical research conduct, laws, regulations, and standards, and compliance with applicable Stryker SOPs and policies.
Responsible for the execution of any other duties assigned by Manager to support division or function needs.
What you need
Bachelor’s degree required; emphasis in health/science-related field preferred.
Master’s degree in scientific related discipline preferred.
Minimum 10+ years of clinical research experience (device, pharmaceutical, biotechnology) in a product development setting required .
Previous people management experience required.
Proficiency in resource planning and financial management (clinical trial budgeting) required
Demonstrated success in developing complex clinical strategies across multiple product lines, and overseeing the design and conduct of multiple clinical trials with a defined pool of resources, timelines, and fixed budgets.
Demonstrated understanding of laws, regulations, standards, and guidance governing the conduct of clinical studies, as well as preparation of clinical documentation in support of regulatory submissions.
Previous field monitoring experience highly desirable.
Previous FDA or other regulatory body trial design experience preferred.
Regulatory Affairs Certified (RAC) or related work experience preferred.
Analytical, strategic thinker with leadership ability and style that demonstrates professionalism and establishes respect.
Ability to think globally and interact with cross-functional teams world-wide.
Excellent organizational and project management skills with a high sense of attention to detail.
$164,500 – 279,500 salary plus bonus eligible + benefits. Actual minimum and maximum may vary based on location. Individual pay is based on skills, experience, and other relevant factors.
Our benefits:
12 paid holidays annually
Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program.
Financial benefits include Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance.
For a more detailed overview of our benefits or time off, please follow this link to learn more: US Stryker employee benefits
About Stryker
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 130 million patients annually. More information is available at stryker.com.
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Stryker is driven to work together with our customers to make healthcare better. Employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required, depending on customer requirements, to obtain various vaccinations as an essential function of their role.
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