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Stryker Neurovascular is seeking a Senior Clinical Trial Specialist to be based hybrid two to three days per week in Fremont, CA.

Who we want

• Meticulous documenters . Detail-oriented people who enjoy maintaining meticulous documentation of reports, metrics, proposals, and presentations.

• Dedicated achievers . People who thrive in a fast-paced environment and are driven to complete projects that meet regulations and expectations.

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

• Analytical problem solvers . People who go beyond, by identifying root causes, evaluating optimal solutions, and recommending comprehensive solutions to prevent future issues.

What you will do

As the Senior Clinical Trial Specialist (Hybrid) , you will work closely with Program Management to delivery high quality site monitoring and management for the Study Operations team within Clinical Shared Services. This will include clinical operations activities through the coordination of our global Clinical staff or within a geographic region.

• Verify that the research site personnel, including the investigators, are conducting the study according to the clinical protocol, “Good Clinical Practices”, and regulatory requirements

• Ensure reporting of adverse events from research site staff to the sponsor and the IRB/IEC

• Verify that the data in the Case Report Forms (CRFs/eCRFs) are in agreement with the source documents (source data verification);

• Review accuracy and completeness of site records (site study file, query resolution, and other data collection tools);

• Verify Investigational Product accountability;

• Complete reporting and ensure management and resolution of all these activities (e.g., visit reports, trial management tracking system);

• Conduct routine monitoring visits on behalf of the clinical trial sponsor.

• Prepare manual of operations for study sites

• Prepare informed consent documents

• Completes clinical project deliverables per schedule

• Ensures audit-readiness

• Communicates relevant information to the PM/LCTS in a timely manner

• Contacts sites on a consistent basis to assess study compliance

• Identify and address noncompliance issues at investigative sites, assist CTS with CAPA, if necessary

• Tracks Screening & Enrollment and identify issues and propose solutions.

• Independently confirms that site documents match Study Master File

• Participates in the conduct and training at Investigator Meetings.

• Maintains expertise in regulations for all geographies and types of studies (IDE, non-significant risk, feasibility, exempt, etc.).

• Generates status reports, oversees process payments, maintain device and regulatory document tracking systems, patient and Case Report Form (CRF) files, required regulatory documents, and central files.

• Collects and tracks regulatory documents (e.g., confidentiality disclosures, IRB approvals, investigator agreements, contracts, study/project annual reports and financial disclosures) to/from study sites using company specific database

• Reviews and collects documents to compile Clinical Events Committee (CEC) packets for CEC adjudication meetings

• Assembles and tracks metrics data.

• Mentors and trains CTCs

• Recommends process improvements to increase team efficiencies and effectiveness.

• Fully support the Quality Policy by building quality into all aspects of the incumbent's work and by maintaining compliance to all quality requirements

What you need

• Bachelor’s Degree required, preferably in a health science field

• 2+ years medical industry experience or equivalent (device, pharmaceutical, biotechnology)

• Previous experience with regulated global trials preferred

• Excellent teamwork and collaboration skills

• Ability to travel up to 40%

$97,900.00 - $156,900.00 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.

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. Stryker 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 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.

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.