Senior Clinical Study Manager - Cary, United States - Stryker Corporation

Description

Stryker Corporation

Why join Stryker?

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Stryker is one of the world's leading medical technology companies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in Medical and Surgical, Neurotechnology, Orthopedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 130 million patients annually. More information is available at

We are currently seeking a Senior Clinical Study Manager, to join our Medical Division. This is an individual contributor Remote position. Preference will be given to candidates that reside in the central and east coast, United States.

Who We Want

• Self directed initiators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.
• Strategic thinkers. People who enjoy analyzing data or trends for the purposes of planning, forecasting, advising, budgeting, reporting, or sales opportunities.
• Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.
• Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.

What you will do

As a Senior Clinical Study Manager, you will assume overall responsibility for executing on the clinical evidence strategy for medical devices, pharmaceutical products, and cosmetics, and support development of this strategy. Create and execute clinical regulatory strategies in support of 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).
• Manage clinical study submissions and content (e.g. Investigational New Drug (IND), 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.
• Responsible for all aspects of clinical research including preparation, study design, execution, and reporting, 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.
• Provide budget input aligned to planned clinical strategy for clinical studies and clinical evaluations.
• 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.
• Review and approve collateral material for the Clinical Affairs function.
• Support development and maintenance of procedures (e.g., to ICH-GCP E6, 21 CFR Part 312, 21 CFR Part 812) 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 other related technical field.
• Advanced degree (MSc, PhD) in biomedical engineering, sciences, health outcomes research, or related field preferred.
• 7+ years of related clinical research experience, candidates with pharmaceutical experience strongly preferred.
  
• Fundamental knowledge and good understanding of GCPs, clinical trial design, study development and project management.
• Demonstrated interpersonal, written, and oral communication skills as well as excellent organizational and time management skills in a fast-paced environment.

$107,800 - $177,000 salary plus bonus eligible + Benefits (Health, Vision, Dental, 401K, Tuition Reimbursement, Employee Assistance Program, Wellbeing Program, Employee Stock Purchase Program). This information reflects the anticipated salary range for this position based on current national data. Actual minimum and maximum may vary based on location. Individual pay is based on skills, experience, and other relevant factors.

Our benefits:

• 12 paid holidays annually
• 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.

For a more detailed overview of our benefits or time off, please follow this link to learn more: US Stryker employee benefits

About Stryker
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company 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 130 million patients annually. More information is available at

Know someone at Stryker?
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Stryker is driven to work together with our customers to make healthcare better. Employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required, depending on customer requirements, to obtain various vaccinations as an essential function of their role.