Senior Clinical Study Manager

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We are currently seeking a Senior Clinical Study Manager, to join our Medical Division. This is an individual contributor fully Remote position, located in the United States. Preference will be given to candidates located in the Midwest or Eastern United States.

What You Will Do

As a Senior Clinical Study Manager, you will assume overall responsibility for executing the clinical evidence strategy for medical devices, and support development of this strategy, to enable new and continued global market access.

• Partner with stakeholders (e.g., Marketing, Research & Development/New Product Development) to develop clinical evidence strategies for the short and long-term. Provide clinical and scientific expertise to influence business strategy and drive informed planning and decision making.
• Create and execute clinical regulatory strategies for new and continued global market access. Author clinical portions of regulatory submissions (e.g., protocols, investigator’s brochures) and clinical evaluations.
• Responsible for all aspects of clinical research including preparation, study design, execution, reporting, budgets, contracts, overseeing monitoring, and ensuring alignment to Good Clinical Practice (GCP). Generate clinical data for the business in alignment with the strategy, including pre- and post-market clinical trials, efficacy studies, registries, surveys, and literature searches.
• Define a study publication strategy in partnership with stakeholders, including preparation of manuscripts, conference presentations/posters, white papers, and customer-facing promotional materials. Assist customers with manuscript/presentation preparation.
• Act as Stryker liaison and build partnerships with clinical research organizations (CROs), data management vendors, medical writers, and other external parties to ensure robust and scalable clinical study and clinical evaluation support.
• Manage clinical study submissions and content (e.g. EU MDR documentation, Investigational Device Exemption (IDE), Institutional Review Board (IRB)).
• Member of Research & Development/New Product Development teams. Support claims development, especially those requiring clinical data to substantiate.
• Support development and maintenance of procedures (e.g., to ICH-GCP E6, 21 CFR Part 812, EU MDR) to ensure effective management of clinical studies and clinical evaluations.
• Support development and maintenance of systems (e.g., electronic trial master file (eTMF), clinical trial management systems (CTMS), consultant management) to ensure effective management of clinical studies.
• Maintain current knowledge in areas of expertise through professional development (e.g., attending conferences and professional association meetings). Share knowledge with Clinical Affairs team and cross-functional partners, as appropriate.
  
  

What You Need

• Bachelor’s degree, preferably with Health Sciences or another related technical field.
• 4+ years of related clinical research experience.
• Fundamental knowledge and good understanding of GCPs, clinical trial design, study development and project management.
  
  

Preferred

• Candidates with medical device experience strongly preferred.
• Demonstrated interpersonal, written, and oral communication skills as well as excellent organizational and time management skills in a fast-paced environment preferred.
• Advanced degree (MSc, PhD) in biomedical engineering, sciences, health outcomes research, or related field preferred.
• $87,600.00 - 143,600.00 USD Annual salary plus bonus eligible + generally eligible for short-term and long-term financial incentives + benefits.  Actual minimum and maximum may vary based on location.  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.