Senior Clinical Study Manager

This is a senior clinical research role focused on developing and executing studies that generate meaningful evidence for regulatory approvals and strategic clinical initiatives.
You will lead pre-market and post-market clinical studies with substantial autonomy, from study design and site selection through enrollment, follow-up, analysis, and reporting.
The role combines clinical operations, evidence strategy, scientific literature assessment, regulatory support, and cross-functional project leadership.
You will collaborate closely with investigators, key opinion leaders, CRAs, CTAs, biostatisticians, data management teams, vendors, and internal stakeholders.
Your work will directly contribute to high-quality clinical evidence, scientific publications, regulatory submissions, and improvements in clinical research strategy.
The environment is highly collaborative and technically rigorous, with opportunities to influence processes, mentor colleagues, and support studies across evolving surgical specialties.
This opportunity is well suited to an experienced clinical research professional who is organized, scientifically curious, self-directed, and comfortable managing complex studies and competing priorities.

The role requires substantial clinical research experience, strong scientific and operational expertise, excellent communication skills, and the ability to independently manage complex studies while collaborating across multidisciplinary teams.

• Experience implementing, supporting, and managing medical device clinical trials.
• Significant knowledge of clinical research and/or outcomes research study design.
• Proven experience developing clinical protocols and informed consent forms and contributing clinical sections to regulatory submissions.
• Demonstrated experience conducting literature searches, reviewing scientific evidence, and critically appraising clinical data.
• Strong ability to interact effectively with physicians, investigators, and other professionals both internally and externally.
• Working knowledge of ICH/GCP, clinical research regulations, and clinical monitoring requirements.
• Experience negotiating clinical research contracts and study budgets.
• Ability to work effectively across cross-functional teams and influence stakeholders toward shared study objectives.
• Strong project management skills, with the ability to manage multiple studies, projects, and shifting priorities simultaneously.
• Excellent communication, presentation, relationship-building, organizational, and attention-to-detail skills.
• Self-starter mindset with the ability to learn quickly, adapt to changing requirements, and independently develop knowledge of different surgical specialties.
• Ability to lead and coordinate clinical project teams involving CRAs and CTAs.
• Strong problem-solving mindset and willingness to work toward demanding timelines when required.
• Minimum advanced degree such as an M.S., Ph.D., or M.D. in a scientific or bioengineering field with at least 5 years of clinical research experience; alternatively, a bachelor's degree in a relevant scientific or bioengineering discipline with at least 8 years of clinical research experience, or approximately 10 years of clinical research experience combined with relevant training.
• Hospital environment experience and familiarity working with nurses and surgeons are preferred.
• Knowledge of statistics, statistical methods, and experimental design is highly desirable.
• Must be willing and able to travel approximately 25–40% depending on business requirements.