• Job Description

  Req#: R491886
  Work Flexibility: Remote

  We are currently seeking a Clinical Project Manager to join our Neurovascular Division to be based remotely in the Pacific or Central time zone.

  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 flow diverting stents, stent retrievers, detachable coils, stents, balloons, guidewires and microcatheters. 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: https://www.youtube.com/watch?v=JANFZrpt1Hg .

  Who we want

  • 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.

  • 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.

  What you will do

  As a Clinical Project Manager , you will manage multiple aspects of clinical operations for assigned clinical trials and product lines while assuring the highest standards of clinical study execution. With guidance from the Clinical Program Manager (CPM), you will lead a cross functional team to through the planning and execution of clinical trials while adhering to budget, scope and timelines. You will also interface with Stryker departmental teams (clinical, divisional, and external) and act as Stryker liaison with site investigators and study coordinators during the conduct of studies focused on stroke prevention and treatment. You will be responsible for providing project leadership with guidance from the Clinical Program Manager, Lead and Sr. CRA.

  • Manages 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, Sr. CRA, CRA, Clinical Trial Coordinator (CTC), CRO, and Stryker 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.

  • Develops project plans and ensures adherence to budget and timelines

  • Executes a project plan including management of schedule, cost, resources and deliverables (e.g. protocol, database development, reporting)

  • Works with CRAs, Data Management, CTCs and Document Control Specialist to create and manage study related documents

  • Works closely with data management to ensure quality of clinical trial data

  • Maintains up to date knowledge of published literature in relevant therapeutic areas including a broad awareness of neurovascular issues

  • Co-monitors with Stryker and CRO Monitors to evaluate and ensure quality of Monitoring Team. Ensures that studies are conducted in accordance with the protocol, GCP / ICH guidelines, FDA regulations, department SOPs, and other applicable local regulations

  • Organizes and participates in meetings – i.e. Study Team Meetings, Investigator Meetings, Monitors’ workshops, and Stryker and CRO Training

  • Assists in preparation of regulatory documents including IDEs, IDE and IRB annual updates, briefing documents, CTAs, as requested

  • Assists in 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

  • Oversees data clarification process as needed in conjunction with Stryker Data Management and selected CROs to insure database lock according to agreed timeline

  • Input/prepare patient informed consent forms (ICFs)

  • Triage CRO and clinical site questions to CPM or Director of Clinical Affairs 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

  • Bachelor’s degree (B.S. or B.A.) required

  • Proficiency in resource planning and financial management (clinical trial budgeting) required

  • 6+ years of experience in all operational aspects of managing clinical trials required

  • Previous experience within a Sponsor organization or a Clinical Research Organization required

  • Previous Clinical experience managing cross functional study teams or CROs in the conduct of US IDE studies

  • Demonstrated working knowledge of GCP, ICH guidelines, and FDA regulations

  • Experience monitoring medical device studies preferred

  $95,100 - $204,000 salary plus bonus eligible + Benefits (Health, Vision, Dental, 401K, Tuition Reimbursement, Employee Assistance Program, Wellbeing Program, Employee Stock Purchase Program). This information reflects the anticipated salary range for this position based on current national data. Actual minimum and maximum may vary based location. Individual pay is based on skills, experience, and other relevant factors.

  #LI-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.

• About the company

  Stryker Corporation is an American multinational medical technologies firm based in Kalamazoo, Michigan.

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