Principal Clinical Data Manager

Stryker   •  

Fremont, CA

Industry: Pharmaceuticals & Biotech


8 - 10 years

Posted 173 days ago

This job is no longer available.

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 who is an expert in the conduct of high quality clinical trials. As a PrincipalClinical Data 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 investigators, colleagues, and vendors to ensure clinical quality and compliance. As a PrincipalClinical Data Manager, you take great pride in mentoring others and delivering high quality results.

Job Summary

The PrincipalClinical Data Manager is an expert in data management  with demonstrated capability to lead clinical data systems development and lead data management activities through a trial life cycle.  Contributes to process improvements and initiatives within the department and mentors and trains junior staff members. Works independently with minimal guidance and direction. Conducts clinical research activities in accordance with Stryker SOPs and applicable regulations/guidelines.

Primary responsibilities:  
• Serve as Data Manager for one or more clinical trials assuming responsibility for selection and application of data acquisition standards, database design (including specification documentation and testing of clinical data collection tools, both CRF and non-CRF, using an EDC system and/or other data collection systems),

• Development and maintenance of the Data Management Plan, data review and query management, data access and visualization, Data Management metrics reporting, database release, and submission related activities.

• Design and/or participate in design of data management documentation and SOPs.

• Participate in preparation and presentation of data management activities and new initiatives.

• Provide training to new or junior staff in clinical data management tasks and SNV processes.

,What you need

• Minimum of BS preferably in Health Sciences, Statistics, MIS or Computer Science. MS or MBA preferred

• 7+ years of clinical data management experience
•Previous 510(k), PMA, NDA, or BLA experience is desired"