This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Clinical Study Manager based in United States.
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.
Accountabilities:
As a Senior Clinical Study Manager, you will independently lead assigned clinical research activities and ensure studies are executed on schedule, within budget, and in accordance with applicable quality, protocol, and regulatory requirements.
- Partner with internal stakeholders, investigators, and KOLs to develop study concepts, designs, protocols, study outlines, and clinical research strategies.
- Plan and execute clinical studies, including site selection, patient recruitment projections, study documentation, and IRB/EC submissions.
- Develop and manage protocols, case report forms, informed consents, clinical trial agreements, and clinical study reports.
- Conduct site qualification, initiation, interim monitoring, and close-out visits through both on-site and remote approaches.
- Monitor clinical studies to ensure regulatory and protocol compliance, data accuracy, and adherence to clinical monitoring plans.
- Perform source data verification for clinical data recorded in EDC systems, case report forms, and data listings.
- Manage study activities from initial findings through remediation, follow-up, and closure while maintaining study timelines and quality standards.
- Support audit and inspection readiness and liaise with clinical sites to address compliance requirements.
- Negotiate clinical research contracts and budgets with external vendors and sites in partnership with legal and management teams.
- Track study progress, financial activities, site payments, and key milestones while providing regular status updates.
- Organize and lead study meetings and other clinical research activities as required.
- Collaborate with biostatisticians on data analysis, interpretation, synthesis, clinical study reports, and scientific publications.
- Mentor junior Clinical Study Managers and provide guidance to CRAs and CTAs on monitoring and study execution needs.
- Ensure compliance with corporate SOPs, ICH/GCP, and applicable US and international clinical research regulations.
- Conduct literature searches and critically appraise scientific evidence to identify knowledge gaps and inform clinical strategies.
- Prepare clinical literature summaries and contribute to the development of clinical investigational protocols and evidence-generation strategies.
- Review and revise Clinical Operations SOPs to support continuous process improvement.
- For post-market research, collaborate with commercial teams to understand market trends and identify opportunities to support broader business objectives through clinical evidence.
- Provide scientific expertise to Health Economics and Outcomes Research activities, including relevant diagnosis or reimbursement codes and clinical outcome selection.
- Work with investigators to develop manuscripts, abstracts, presentations, and posters for scientific meetings and publications.
- Support regulatory submissions and approvals for pre-market clinical studies and 510(k) submissions, including responses to regulatory questions concerning study design and results.
- Drive project teams involving CRAs and CTAs and provide management with timely, relevant study updates.
- Help strengthen clinical research processes and evidence-generation capabilities through effective problem solving and proactive project leadership.
Requirements
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.
Benefits
- Competitive compensation: Market-competitive compensation packages that may include base pay, incentives, benefits, and equity.
- Career development: Opportunities to grow clinical research expertise while contributing to meaningful healthcare and medical technology initiatives.
- Scientific impact: Work on clinical evidence-generation programs that can support regulatory approvals, publications, and improved clinical strategies.
- Cross-functional exposure: Collaborate with clinicians, investigators, biostatisticians, regulatory professionals, data teams, and other specialists.
- Leadership opportunities: Mentor junior clinical study professionals and contribute to clinical operations process improvements.
- Meaningful work: Contribute to clinical research initiatives designed to improve healthcare outcomes and advance minimally invasive surgical care.
- Compensation flexibility: Actual compensation is determined based on experience, skills, qualifications, job level, and other applicable factors.
- Workplace support: Reasonable accommodations are available to qualified individuals with disabilities throughout the application and interview process.
- Additional requirements: Depending on the role and work environment, proof of vaccination against certain diseases may be required.
- Regulatory considerations: Certain roles may be subject to applicable US export-control requirements, with candidates notified if additional authorization or technology-control measures are required.
How Jobgether works:
We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.
We appreciate your interest and wish you the best!
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