Clinical Excellence Manager, Data & Systems Management (Remote)

Work Flexibility: Remote

Stryker is hiring a  This position is Remote, supporting our Neurovascular Division.

What you will do

As the Manager of Clinical Excellence, you will be working with key stakeholders, position manages the overall operation of Clinical Information Systems and Data Management. This includes functional implementation, analysis, testing and documentation, assisting with the development of long-range and short-range plans for the systems, and coordinating the functional operation of new and existing systems. Working with key stakeholders, the role will develop and deliver agreed Clinical Technology Systems and Data Management imperatives, drive innovation, automation and promote transparency within the organization regarding technology, application of systems, and processes.

• Coordinate the development of systems plans. Establish objectives, priorities, time allocations and deadlines for staff.  Execute plans and provide regular status reports to keep management informed of progress and project issues.
• Provide leadership in the justification, acquisition, implementation and integration of new products and technologies into the clinical organization, coordination across Clinical and Medical affairs.
• Plan, lead, coordinate, and collaborate with IT teams/management along with internal and external operational partners, business and clinical, as well as external entities as necessary to lead mid to large projects through the appropriate phases of implementation.
• Manage and direct staff in providing first-line systems software support, troubleshooting and problem resolution services, liaising with corporate IT and software vendors as appropriate. Manage the analysis, development, testing, documentation, and maintenance of in-house systems to enhance or customize the benefit received from vendor-supplied products.
• Leads the Data Management Team ensuring the continuous improvement of the data management function and ensure operational compliance.  Ensure planning and co-ordination of project work together with Statistics and COPs staff. 
• Manage the contracting out of data management project work to CROs as required.
• Ensure that validation documentation is adequate for all the major products under the responsibility of the Clinical Systems team and follows the relevant regulatory guidelines by maintaining close collaboration with corporate IT teams.
• Ensure processes (SOPs) and subsequent documentation of clinical systems, including support documentation is maintained.
• Manage, through the coordination and efforts of the Systems team, applications supporting the clinical and medical affairs team.
• Lead meetings to escalate trends, issues, and establish standards based on current industry standards, while problem solving and seeking appropriate endorsement across study teams and functions. Communicate ideas, solutions, and standards.
• Identifies Clinical related business system needs. May lead or participate in the creation and presentation of the business case, system selection, validation, and implementation of systems.
• Maintain electronic Case Report Forms (eCRF) through the lifetime of the study, accommodating update requests as a result of study team or user feedback.
• Establishes data quality standards for given study through development of the Data Handling Protocol/Data Management Plan (DMP) and maintains this document throughout lifecycle of study project and ensures it is followed, and standards are met by working closely with study team (Project Manager, Monitor, Statistician)

What you need

• A minimum of a bachelor’s degree (B.S. or B.A.) required.
• 8+ years’ experience managing clinical systems. Experience would ideally be in neurovascular.
• Experience with back-end development, database design, and programming (e.g. SQL, Python, R, PowerBI).
• Strong proficiency in operation of computer systems, knowledge in CTMS, EDC, eTMF, DICOM/image management, and a proven track record experience in delivery of Clinical IT system projects.
• Experience validating, qualifying, and auditing vendors, systems and software
• Knowledgeable in virtualization, data management, and storage systems
• Excellent verbal and written communication skills.
• Exceptional organizational skills, attention to detail and follow through.
• Well-developed interpersonal skills and the ability to work well independently as well as with colleagues and customers.
• Ability to handle multiple tasks simultaneously effectively and efficiently with precision and adapt to changes in responsibilities and workloads.
• Must be professional, possess a high degree of urgency and self-motivation, and have a strong work ethic

Preferred

• Excellent verbal and written communication skills.
• Exceptional organizational skills, attention to detail and follow through.
• Well-developed interpersonal skills and the ability to work well independently as well as with colleagues and customers.
• Ability to handle multiple tasks simultaneously effectively and efficiently with precision and adapt to changes in responsibilities and workloads.
• Must be professional, possess a high degree of urgency and self-motivation, and have a strong work ethic.

• $127,200.00 - 208,000.00 USD Annual salary plus bonus eligible + benefits. Actual minimum and maximum may vary based on location. Individual pay is based on skills, experience, and other relevant factors.