(Remote) Clinical Project Manager ($95100.00 - $204000.00 / Year)

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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

• 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 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.

• Organizes and participates in meetings - i.e. Study Team Meetings, Investigator Meetings, Monitors' workshops, and Stryker and CRO Training
• Proactively identifies risks and leads team members to mitigate risks in timely fashion
• Assists in preparation of regulatory documents including IDEs, IDE and IRB annual updates, briefing documents, CTAs, as requested
• 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
• Develops project plans and ensures adherence to budget and timelines
• 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
• 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
• Executes a project plan including management of schedule, cost, resources and deliverables (e.g. protocol, database development, reporting)
• Works closely with data management to ensure quality of clinical trial data
• Works with CRAs, Data Management, CTCs and Document Control Specialist to create and manage study related documents
• Tracks and reports on the progress of assigned clinical trials including budget and timelines.
• Manages planning and communication with cross-functional teams to ensure proper execution and conduct of the trial
• 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)
• 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.