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Manager, Clinical Research (Remote)

Manager, Clinical Research (Remote)

Minnesota StaffingMinneapolis, MN, US
Hace 1 día
Tipo de contrato
  • A tiempo completo
  • Teletrabajo
Descripción del trabajo

Manager, Clinical Research

The Manager, Clinical Research leads a team responsible for the planning, execution, and oversight of clinical studies supporting the safety and effectiveness of Stryker's medical devices. This role drives operational excellence in clinical project management, ensures compliance with regulatory requirements, and partners cross-functionally to enable high-impact evidence generation aligned with business objectives. In addition, this role is responsible for the development of staff in the support of Stryker's business objectives and timelines. This position is ideal for a collaborative, data-driven leader who thrives in a dynamic environment and is passionate about advancing patient outcomes through innovation in clinical research.

What You Will Do

  • Develop and execute clinical research strategies, processes, and performance metrics that support organizational and regulatory goals.
  • Contributes to the clinical strategy to demonstrate safety, efficacy, economic, and quality of life outcomes for the performance of Stryker products and solutions.
  • Lead, mentor, and develop a high-performing clinical project team.
  • Foster a culture of accountability, collaboration, and continuous improvement.
  • Oversee the planning, execution, and close-out of clinical studies (IDE, post-market, and observational).
  • Ensure studies are completed on time, within scope, and in accordance with GCP, ISO 14155, and applicable FDA / International guidelines.
  • Maintain clinical timelines, budgets, and resource allocation plans; provide quarterly forecasts and variance analyses.
  • Develops and provides oversight in the development of critical clinical study documents.
  • Creates and maintains Clinical SOPs, systems and processes across study trials.
  • Serve as a Subject Matter Expert (SME) for clinical processes and represent Clinical Affairs in internal and external audits.
  • Supports and develops short-term and long-term planning and execution of clinical research including multi-center and investigator-initiated studies.
  • Reviews, evaluates, and compiles files and reports for regulatory and reimbursement authorities.
  • Develop strong customer and field personnel relationships ensuring appropriate sponsor oversight of clinical research centers.
  • Deliver site training, updates, and study communication materials to sites.
  • Strong clinical process acumen and ability to drive clinical excellence activities.
  • Partner with Regulatory Affairs, Quality, R&D, Global Supply, Finance, Sales, and Marketing to align clinical programs with strategic business priorities.
  • Communicate study results, progress, and key insights to executive stakeholders.
  • Provide input into product development and post-market surveillance activities.
  • Prepares outlines, summaries, status reports, etc. for distribution and communication with other departments and executive leadership.
  • Identify and implement process improvements to enhance clinical trial quality, efficiency, and compliance.
  • Develop and track KPIs, metrics, and dashboards to monitor clinical performance and outcomes.

What You Need

  • Bachelor's degree in Life Sciences, Biomedical Engineering, Nursing, or related discipline.
  • Minimum of 8 years of clinical research experience, including 2+ years of people management and / or leadership of critical clinical programs.
  • Strong knowledge of FDA, ISO 14155, and ICH / GCP clinical research regulations.
  • Proven experience managing IDE and post-market medical device trials.
  • Preferred
  • Advanced degree (MS, MPH, or equivalent) or certification in Clinical Research (CCRA, CCRP, etc.).
  • Experience in both medical device and pharmaceutical industries.
  • Demonstrated experience in data analysis, trend reporting, and audit readiness.
  • Exceptional project and people management skills.
  • Strong analytical and critical thinking capabilities.
  • Demonstrated ability to lead through influence across diverse functions.
  • Excellent communication, presentation, and collaboration skills.
  • Proficiency in clinical trial management systems (CTMS), EDC platforms, and electronic document management systems.
  • Strong commitment to quality, integrity, and continuous improvement.
  • Ability to thrive in a fast-paced, evolving environment with multiple competing priorities.
  • $121,400.00 - $198,600.00 salary plus bonus eligible + benefits.
  • Individual pay is based on skills, experience, and other relevant factors.
  • Health benefits include : Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include : Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance.

    Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.

    Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.

    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.

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