Stryker is one of the world’s leading medical technology companies offering a diverse array of innovative medical technologies, including reconstructive, medical and surgical, and neurotechnology and spine products. We are currently seeking a Senior Clinical Project Manager join our Neurovascular Division located in Fremont, CA or remotely anywhere in the US.
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. In February 2019, Stryker Corporation (NYSE:SYK), was named one of the FORTUNE 100 Best Companies to Work For, ranking 11 out of 100. If you join our organization; you will be working to “Make Stroke History” as stroke is devastating; 1 of 20 deaths are stroke related according to the CDC. Watch this video and see how Stryker is making a difference: URL blocked - click to apply.
Who we want:
Strategic thinkers. People who enjoy analyzing data or trends for the purposes of planning, forecasting, advising, budgeting, reporting, or sales opportunities.
Collaborative partners. People who build and leverage cross-functional relationships to bring together 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.
Data translators. Highly effective communicators who can transform data findings into recommendations to compose reports and executive level presentations.
Meticulous documenters. Detail-oriented people who enjoy maintaining meticulous documentation of reports, metrics, proposals, and presentations.
Self-directed initiators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.
What you will do:
As a Senior Clinical Project Manager you will manage Stryker’s clinical trials to assure the highest standards of clinical study execution. You will be responsible for overseeing all aspects of clinical trial conduct including budget development and oversight, CRO and vendor selection and oversight, day to day trial oversight to ensure patient safety, adherence to clinical study and investigator contracts, protocol and appropriate safety regulations, and data integrity while providing mentorship to your clinical trial team. You will ensure compliance to budgets and SOPs, organize and lead trial meetings, maintain study timelines, track resource loading, and provide study updates to internal product and management teams. Additional responsibilities include:
- Lead various teams (including CRAs, CTCs, Data Management, biostats) to create and manage study related documents.
- Organizes and participates in meetings – i.e. Study Team Meetings, Investigator Meetings, Monitors’ workshops, and CRO Training.
- Oversee data clarification process to insure database lock according to agreed timelines.
- Maintain up to date knowledge of published literature in relevant therapeutic areas including a broad awareness of neurovascular issues.
- Co-monitor with internal CRAs to evaluate and ensure quality of monitoring outcomes and ensure studies are conducted in accordance with the protocol, GCP / ICH guidelines, FDA regulations, and departmental SOPs.
- Lead the preparation of trial documents in support of regulatory requirements including IDE, IDE and IRB annual reports, briefing documents, and investigator agreements.
- Provide input and review of in-house operations SOPs, guidelines, and systems.
- Develop and maintains positive relationships both internal and external to project, including site personnel (KOLs, PIs, Study coordinators).
- Demonstrate thorough knowledge of clinical research conduct, laws, regulations, and standards, and compliance with applicable Stryker SOPs and policies and coach others in the appropriate application of these standards.
- Proactively risks and lead team members to mitigate risks in timely fashion.
- Manage the triage of clinical trial questions to appropriate team members (Program Manager or Director as appropriate).
- Fully support the Quality Policy by building quality into all aspects of the incumbent's work and by maintaining compliance to all quality requirements (including but not limited to being current on all training requirements for the incumbent's position and documenting that training).
What you need:
- A minimum of a bachelor’s degree (B.S. or B.A.) or experience as a Medical Healthcare Professional required.
- A minimum of 8 years of experience in all operational aspects of managing clinical trials.
- Experience managing US IDE trial is required.
- Must have demonstrated problem solving abilities in overseeing clinical trials.
- Proficiency in project management (Microsoft Project or similar software), resource planning, and clinical trial budgeting required.
- Certified Clinical Research Associate (CCRA) preferred.
- Project Management Professional Certification preferred.
- A Master’s degree in business management preferred.
- Must have a demonstrated working knowledge of GCP, ICH guidelines, and FDA regulations.
- Experience monitoring medical device studies required.
- Strong leadership and management skills preferred.
Work From Home: Yes
Travel Percentage: 20%
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.