Clinical Project Manager in Fremont, CA at Stryker Corporation

Date Posted: 10/25/2018

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.

Together we can advance our capabilities and continue to improve healthcare and the lives of patients. Stryker is well positioned to continue serving the worldwide medical community for generations to come. Do you have what it takes to change the world with us?

Who we want

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.
Teammates. Supports, encourages, and inspires others.
Communicators. Articulates well and expresses ideas effectively.

What you will do
 
We are looking for a customer focused team player skilled in the planning, development, and execution of clinical trials, study budgets, and program timelines. As a Clinical Project Manager you will manage a cross functional team through the implementation, conduct, and completion of clinical trials while also acting as a Stryker liaison with site investigators and study coordinators. You will proactively communicate with Stryker management, study investigators, colleagues, and vendors to ensure clinical quality and compliance to applicable regulations and SOPs. In support of delivering high quality results you will provide valuable leadership training and mentoring to team members and others within the Clinical Affairs department.  

The Clinical Project Manager will manage multiple aspects of clinical operations for assigned clinical trials/product lines to assure the highest standards of clinical study execution with guidance from Sr./Lead CRAs and Program Manager. 
 

•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, CRO and vendor personnel. Supports selection and provides oversight and management of CROs, consultants and vendors.

•Prepares, manages, tracks and reports on the progress of assigned clinical trials including budget and timelines.

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

•Develops project plans and ensures adherence to budget and timelines

•Works with Clinical Trial Managers, Data Management, Clinical Trial Assistant and Document Control Specialist to create and manage study related documents and data.

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

•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 department SOPs.

•Organizes (or assists with organizing) and participates in meetings – i.e. Study Team Meetings, Investigator Meetings, Monitors’ workshops, and CRO Training.

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

What you need


*Minimum Qualifications
Bachelor's degree in life sciences, or equivalent in health/science related field. 

  • Proficiency in resource planning and financial management (clinical trial budgeting) required.  
  • Certified Clinical Research Associate (CCRA certification) preferred
  • Minimum of 4 years experience in all operational aspects of managing clinical trials in a leadership role for studies conducted under US IDEs
  • Demonstrated working knowledge of GCP, ICH guidelines, and FDA regulations
  • Well organized and detail oriented, strong written and verbal communication skills
  • Experience monitoring medical device studies preferred

Work From Home: No

Travel Percentage: Up to 25%

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.

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