Senior Clinical Program Manager

This is a fully remote position, open to applicants in United States.

📋 Description

• Deliver comprehensive clinical project management guidance, prioritization, and ensure global study objectives are met within specified timelines and budget constraints.

• Oversee a clinical operations team managing several studies that align with essential business strategies.

• Collaborate closely with study managers, support teams, and monitors to maintain high standards of study quality.

• Provide cross-functional insights to development programs and communicate study status updates and responses to Marketing, Regulatory, R&D, Market Access, Medical Affairs, and PMO teams.

• Assist the Clinical Operations Director in achieving study objectives and supervise program/study-level outsourcing.

• Take proactive measures to resolve study and program-related issues.

• Promote continuous process enhancement by identifying operational deficiencies and executing optimized clinical operations solutions.

• Lead strategic initiatives that improve efficiency, transparency, quality, and compliance across clinical programs and departmental processes.

• Utilize critical thinking and scientific rigor in the design and evaluation of clinical study protocols.

• Manage multiple cross-functional clinical project teams across the clinical portfolio.

• Ensure compliance with ethical, regulatory, and GCP standards throughout studies.

• Evaluate the assigned study portfolio within 30 days, identify essential actions, and implement suitable plans.

• Engage with Clinical Science, the medical community, internal and external stakeholders, and the Clinical Operations Director to address clinical and regulatory requirements.

• Recognize study and program risks and formulate mitigation strategies.

• Set priorities for study activities in collaboration with Operations, Monitoring, and Data Management teams.

• Ensure effective communication with global stakeholders.

• Oversee the delivery of multicenter global clinical studies to meet required inclusion rates, timelines, and budgets.

• Relay program updates and results to both internal and external stakeholders.

• Assist in creating and distributing corporate-wide dashboards for significant initiatives.

• Provide expert insights during STC meetings and facilitate study-related decision-making.

• Contribute clinical expertise to Product Development teams and incorporate clinical considerations into product strategy, innovation planning, and lifecycle management.

• Support long-term clinical strategies and the prioritization of studies, publications, and evidence-generation requirements.

• Mentor, train, and support project managers in protocol development and project management methodologies, tools, and techniques.

• Develop business cases that inform strategic decision-making.

• Educate and mentor staff in clinical practices, project management principles, methodologies, and procedures.

⛳️ Requirements

• At least 8 years of clinical project/program management experience within a medical device setting, demonstrating consistent professional growth.

• Proficient project management skills.

• Capability to transform strategic plans into prioritized product, development, and/or operational business objectives.

• Excellent written, verbal, and interpersonal communication skills; a writing sample will be required from top candidates.

• Ability to troubleshoot and make sound decisions under pressure while managing multiple meetings simultaneously.

• Exceptional organizational skills.

• High proficiency in MS Office applications: Outlook, Word, Excel, and PowerPoint.

• Experience in a fast-paced, complex, dynamic, multi-cultural business environment.

• Ability to establish and maintain effective relationships with both internal and external contacts.

• Capable of working independently as well as in group settings.

• Ability to foster and sustain effective working relationships with others.

• Fluent in English.

• Proficiency in an additional European language is a plus.

• Bachelor’s degree in a scientific discipline or equivalent practical experience.

• Willingness to travel for business 35% or more of the time.

🏝️ Benefits

• Health benefits – Medical, Dental, Vision

• Personal and Vacation Time

• Retirement & Savings Plan (401K)

• Employee Stock Purchase Plan

• Training & Education Assistance

• Bonus Referral Program

• Service Awards

• Employee Recognition Program

• Flexible Work Schedules

• Discretionary annual bonus