Clinical Program Manager, (Remote) | Stryker

Job title: Clinical Program Manager, (Remote)

Company: Stryker

Job description: Work Flexibility: Remote or Hybrid or OnsiteStryker 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 atWe are currently seeking a Clinical Program Manager, to join our Sports Medicine Business. This is an Individual Contributor fully remote position. Preference will be given to candidates located in the Denver or San Jose area.Who We WantCollaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.Self-directed initiators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.Meticulous documenters. Detail-oriented people who enjoy maintaining meticulous documentation of reports, metrics, proposals, and presentations.Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes – finding ways to simplify, standardize and automate.What you will doOversees a multifaceted clinical studies program, encompassing IDE, post-approval, post-market surveillance, feasibility, marketing studies, and / or surgeon-initiated studies. The primary emphasis is on managing program cost, schedule, and performance while also prioritizing effective teamwork, decision-making, and issue resolution. It also entails maintaining consistency in clinical study processes across trials, overseeing operational aspects of trials, adhering to SOPs, GCP, and country regulations, including site and vendor selection and budget preparation. The individual ensures adherence to trial protocols, monitors progress, and addresses issues with team members and managers. Additionally, they contribute to the clinical development strategy and may develop recruitment strategies for clinical studies within the program.

• Lead multi-disciplinary team of personnel on clinical project team including setting goals, schedules, and budgets for project.
• Design, develop and establish Investigational Plans in conjunction with physician advisors.
• Responsible for implementing study protocols in line with local Institutional Review Board (IRB) or Ethics Committee (EC) requirements, local regulatory guidelines and Company policy ensuring that all studies are conducted in a compliant and ethical manner.
• Create and gain management approval for study budgets.
• Manage all the end-to-end study costs within the approved time and budget parameters ensuring a cost-effective, ethical and results focused, publishable study in order to support the franchise business requirements as well as pricing and reimbursement considerations.
• Understand the medical literature in the subject field in order to act as clinical representative to physician advisors, regulatory agencies, internal and external consultants, and other Stryker departments.
• Oversee Investigator qualification visits, monitoring visits, and study close-out visits.
• Responsible for resolving issues and giving direction to Clinical Research Associates and sites.
• Establish and define the standards required within the study process including but not limited to training, CRF completion, data capture, serious adverse events notification.
• Provide guidance for IRB or EC submissions and renewals, site training, and contracts. •Communicate and collaborate with Data Management and/or CROs on study set-up for databases, edits and reports.
• Responsible for designing study-specific CRFs (Case Report Forms) in close collaboration with Data Management.
• Liaise between study site personnel and sponsor regarding all study-related issues.
• Develop and track study metrics on site performance and devise and implement corrective actions when required.
• Prepare periodic study status reports for sites and maintain open communication with sites.
• Oversee the preparation of annual study progress reports and final reports, to include clinical and radiographic data, for regulatory authorities, Investigators and IRBs.
• Provide support to Regulatory Affairs in submission of IDEs, amendments, supplements and other regulatory submissions, especially with regard to clinical issues.
• For IDE studies, actively participate in submissions and review processes.
• Drive the entirety of the clinical study process through to publication.
• Manage/facilitate all investigator meetings to ensure that study protocols and timelines are adhered to.
• Apply excellent (best in class) conduct of clinical research studies.
• Strong up-to-date knowledge of clinical study best practice and product knowledge as well as global legislative changes that may influence future study requirements relating to product or pricing.

What you need

• A minimum of a Bachelor’s Degree (B.S. or B.A.) in science or health care field required
• Master’s or Ph.D. or other higher degree in health-related field (PhD/NP/MS/MPH) is preferred
• 8 years of relevant clinical research experience with minimum of 4 years of clinical study management experience
• Required experience in Sponsor Medical Device Study Management
• Required clinical research or project management certification (eg, CCRP, ACRP, PMP)
• Preferred experience in leading Sports Medicine or Orthopedic Clinical Programs
• Preferred experience leading cross functional teams
• Demonstrated understanding of laws, regulations, standards, and guidance governing the conduct of clinical studies, as well as preparation of clinical documentation in support of regulatory submissions
• Demonstrated success in assisting in solving complex strategies across multiple functions within the department in support of conducting multiple global clinical trials across multiple franchises
• Proactive, energetic, self-assured professional with high personal integrity and ability to develop good interpersonal relationships with stakeholders
• Analytical, strategic thinker with leadership ability and style that demonstrates professionalism and establishes respect.
• Excellent teamwork skills
• Excellent communication and presentation skills (articulate and persuasive)
• Excellent organizational and project management skills with a high sense of attention to detail

$ 124,100.00 – 203,000.00 USD Annual salary plus bonus eligible + generally eligible for short-term and long-term financial incentives. Benefits (including but not limited to 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.Travel Percentage: 30%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.Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.

Expected salary:

Location: Denver, CO

Job date: Thu, 29 Aug 2024 00:15:30 GMT

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