Clinical Program Manager - 23400BR - EN in Fremont, CA at Stryker Corporation

Date Posted: 3/24/2018

Job Snapshot

Job Description

Who we are
At Stryker Neurovascular, our approach to Complete Stroke Care centers around a culture of innovation and partnerships - from introducing breakthrough technologies and investigating leading-edge therapies, to providing ongoing training and improving reimbursement.

The Stryker Neurovascular Clinical Team is changing the landscape of stroke care by providing robust clinical evidence. Our team continues to push the boundaries of science and research.

We are dynamic, passionate, and accomplished individuals who thrive on tackling challenging assignments. We conduct revolutionary trials studying innovative devices such as stent retrievers, coils, stents for adjunctive use with coiling, and intracranial atherosclerotic stents. We value the strengths of each team member and are focused on individualized development opportunities that align with career aspirations.

Do you have what it takes to change the world with us?

Who we want
Leaders. Leads, establishes clear objectives and inspires others.
Collaborators. Collaborates and builds relationships with internal and external stakeholders.
Achievers. Thrives on accomplishing tasks and constantly driven to do more.
Challengers. Challenges the status quo and build better solutions or processes.
Communicators. Articulates well and expresses ideas effectively.

What you will do
We are looking for a customer focused team player who leads teams and individuals and is expert in the conduct and interpretation of high quality clinical trials (Ischemic Stroke Franchise). As a Clinical Program Manager, you demonstrate the ability to work in a fast paced environment and provide leadership to others on the team. You are able to take initiative and complete tasks with high attention to detail and accuracy. You proactively communicate with project teams, investigators, colleagues, and vendors to ensure results as well as clinical quality and compliance. As a Clinical Program Manager, you take great pride in coaching and developing others and delivering high quality results.

•Responsible and accountable for global clinical studies as part of a therapeutic program product strategy, leveraging resources, expertise, and knowledge to achieve project deliverables.

•Hires, trains, develops, mentors, and supervises Clinical Project Managers and other clinical staff. Develops staffing plans for therapeutic area or region.

•Participates in the development of global clinical strategies for assigned therapeutic area(s) in collaboration with Regulatory Affairs, Marketing, Research & Development, Reimbursement and Outcomes planning, and regions to obtain approvals as efficiently as possible. Also supports regulatory/clinical strategies as the clinical representative for the therapeutic program.

•Oversees therapeutic area budget and resources; ensures project managers prepare and manage budgets for projects.

•Oversees development and/or provides input and review to study protocols and associated clinical study documentation drafted by project team members (e.g., Site Selection, CRFs, Investigational Device forecasts, Monitoring Plan, etc.)

•Represents the therapeutic area and interfaces with Key Opinion Leaders for investigator and coordinator meetings as well as clinical advisory board meetings.

•Provides oversight of clinical trials to ensure that safety concerns and/or adverse events are identified and appropriate responses are developed and implemented. Helps determine reportability of adverse events and other clinical trial issues to regulatory agencies.

•Manages and oversees data release and review meetings for projects in therapeutic area; reviews and participates in finalizing and approving final manuscript and final reports for projects.

•Reviews and approves corrective action plans for studies, andp articipates in internal/external audits as a subject matter expert.

•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.

Job Requirements

What you need
•8+ years clinical research experience (device, pharmaceutical, biotechnology) in a product development setting
•Bachelor's level degree or equivalent in health/science related field
•Master’s Degree and/or Certificate Degree in Clinical Research or CCRA (Certified Clinical Research Associate) credentials preferred
•Proficiency in resource planning and financial management (clinical trial budgeting) required
•Previous FDA or other regulatory body trial design experience preferred

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