Clinical Study Manager (Remote)

Clinical Study Manager (Remote)

Stryker is hiring a Clinical Study Manager to support our Medical this role you will be responsible for executing the clinical evidence strategy for medical devices and support the development of this strategy to enable new and continued global market access.

What you will do

• Partner with cross-functional teams (e.g. Marketing R&D/NPD) to develop short- and long-term clinical evidence strategies providing scientific expertise to guide business decisions.
• Develop and execute clinical regulatory strategies to support global market access including authoring clinical sections of regulatory submissions and evaluations.
• Lead all aspects of clinical research: study design execution reporting budgeting contracting monitoring and ensuring compliance with Good Clinical Practice (GCP).
• Define and implement publication strategies including manuscripts conference presentations white papers and promotional materials support customer publication efforts.
• Serve as Strykers liaison with CROs data vendors medical writers and other external partners to ensure scalable and high-quality clinical support
• Manage clinical study documentation and submissions (e.g. EU MDR IDE IRB) supporting claims development that require clinical validation
• Support the development and maintenance of procedures and systems (e.g. eTMF CTMS) to ensure effective management of clinical studies and evaluations in compliance with global regulations.
• Generate clinical data aligned with business strategy through pre- and post-market trials efficacy studies registries surveys and literature reviews.

What you need

Basic Qualifications:

• Bachelors degree preferably with Health Sciences or related technical field.
• 4 years of relevant clinical research experience preferred in clinical study management.

Preferred Qualifications:

• Experience in the Medical Device Industry
• Knowledge of Digital Health technologies and trends
• Advanced degree (MSc PhD) in health sciences biomedical engineering health outcomes research.
• Clinical research or project management certification (e.g. CCRP ACRP PMP).

$87600.00 - $186700.00 salary plus bonus eligible benefits. Individual pay is based on skills experience and other relevant factors.