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 Senior Clinical Project Manager to join our Neurovascular Division to be based 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. 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 Senior Clinical Project Manager.
Who we want
Business-oriented evaluators. People who effectively interpret information to demonstrate the effects of business initiatives, regulation and industry trends for sales, management and leadership teams.
Data translators. Highly effective communicators who can transform data findings into recommendations to compose reports and executive level presentations.
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.
What you will do
As the Senior Clinical Project Manager, you will manage multiple aspects of clinical operations for assigned clinical trials/product lines to assure the highest standards of clinical study execution. You will be responsible for managing all aspects of a clinical trial or multiple clinical trials including CRO & vendor selection and oversight to ensure patient safety, adherence to the contract, protocol and appropriate safety regulations and data integrity, provides oversight and mentorship to clinical project managers. You will ensure compliance to SOPs, organize and lead CRO/vendor meetings, maintain study timelines, and provide study updates to internal line functions and management team.
- Provides oversight and leadership to project managers.
- Leads planning and communication with cross-functional teams to ensure proper execution and conduct of the trial.
- Serves as primary contact and resource for Lead CRA, CRO and vendor personnel. Supports selection and provides oversight and management of CROs, consultants and vendors.
- Tracks and reports on the progress of assigned clinical trials including budget and timelines.
- Executes project plans including management of schedule, cost, resources and deliverables (e.g. protocol, database development, reporting).
- Develops project plans and ensures adherence to budget and timelines.
- Leads various teams (including CRAs, CTCs, Data Management, biostats) to create and manage study related documents.
- Oversees data management and analysis to ensure quality of clinical trial data.
- Oversees data clarification process as needed in conjunction with selected CRO and insure database lock according to agreed timeline.
- Maintains up to date knowledge of published literature in relevant therapeutic areas including a broad awareness of neurovascular issues.
- Co-monitors with CRO’s Monitors to evaluate and ensure quality of CRO Monitoring Team. Ensures that studies are conducted in accordance with the protocol, GCP / ICH guidelines, FDA regulations and departmental SOPs.
- Ensures appropriate oversight of CRO and vendors.
- Organizes and participates in meetings – i.e. Study Team Meetings, Investigator Meetings, Monitors’ workshops, and CRO Training.
- Leads the preparation of clinical documents in support of regulatory requirements including IDEs, IDE and IRB annual updates, briefing documents, CTAs, as requested.
- Provides input and review of the development of in-house operations SOPs, guidelines and systems.
- Develops and maintains positive relationships both internal and external to project, including site personnel (KOLs, PIs, Study coordinators).
- 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.
- Proactively identifies risks and leads team members to mitigate risks in timely fashion.
- Manage the triage of CRO and clinical site questions to appropriate team members (Program Manager or Director as appropriate).
- Prepares and manages clinical trial site budgets.
- Fully supports 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 Master’s degree in business management preferred.
- A minimum of 8 years of experience in all operational aspects of managing clinical trials required.
- Proficiency in resource planning and financial management (clinical trial budgeting) required.
- A minimum of 2 years of experience in a Clinical Operations role within a Medical Device environment required.
- Previous experience within a Sponsor organization or a Clinical Research Organization required.
- Certified Clinical Research Associate (CCRA) preferred.
- Project Management Professional Certification 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.
- Must have demonstrated problem solving abilities in overseeing clinical studies working with external CROs.
Work From Home: Remote
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.