Senior Project Manager Clinical

Primary Function of Position:

The Senior Project Manager Clinical Workstream plays a pivotal role in supporting the clinical development and clinical affairs components of Future Forward BU. This position is central to guiding the planning and execution of pre-clinical studies early feasibility human studies and pivotal studies within a medical device development framework. The Senior Project Manager is accountable for providing both strategic leadership and tactical execution across all phases of clinical research ensuring the successful delivery of clinical objectives that directly influence the advancement of innovative medical devices.

An ideal candidate would provide strategic direction by translating the Future Forward initiatives vision into actionable clinical development roadmaps setting priorities and aligning resources. Tactically the role involves hands-on management of daily project operations troubleshooting study execution challenges coordinating site activities and ensuring milestones are achieved on time and within scope. Examples include developing bottoms up schedules identifying critical path risk registers and conducting detailed project reviews to drive continuous improvement.

Roles & Responsibilities:

• Lead the planning initiation and management of clinical workstream activities across pre-clinical early feasibility and pivotal study phases ensuring alignment with program milestones and regulatory expectations.
• Develop and execute comprehensive project plans that reflect the Future Forward initiatives strategic objectives integrating timelines resource allocation and deliverable tracking for all clinical and pre-clinical activities.
• Coordinate with cross-functional teams including R&D regulatory clinical affairs clinical development engineering quality and operations to ensure seamless integration of clinical deliverables within the product lifecycle.
• Partner with clinical development engineers to define experimental designs establish study requirements and provide technical support for pre-clinical studies ensuring robust data generation and protocol compliance in both GLP and non-GLP settings.
• Oversee the preparation submission and maintenance of regulatory documents and study protocols in compliance with applicable standards and regulations (e.g. EC IDE submissions) and ensure that pre-clinical documentation meets both internal and external audit requirements.
• Manage logistics for product availability in pre-clinical and clinical studies including coordinating shipments tracking inventory and ensuring that devices and ancillary materials are delivered on time to appropriate sites.
• Implement and monitor procedures for product return following study completion ensuring proper reconciliation documentation and disposition in accordance with quality and regulatory guidelines.
• Support the clinical affairs team by creating and maintaining tools to monitor study progress proactively identify risks and implement mitigation strategies to ensure project timelines and budgets are met.
• Facilitate regular clinical domain meetings providing clear status updates to the program core team capturing action items and communicating decisions to relevant stakeholders.
• Coordinate with the clinical development team to manage interactions with internal and external laboratories including scheduling documentation transfer and issue resolution while fostering engagement with key opinion leaders (KOLs) to inform study design execution and data interpretation.
• Ensure high-quality documentation reporting and data integrity across all clinical and pre-clinical activities supporting audit readiness and inspection activities for clinical trials as needed.
• Contribute to the continuous improvement of clinical project management processes and best practices with a focus on enhancing cross-functional collaboration and operational efficiency within the clinical development framework.

Qualifications :

Skills Experience Education & Training:

• Bachelors degree in Life Sciences Engineering or a related field; advanced degree (MS PhD or equivalent) preferred.
• Minimum of 5 years experience in clinical project management with at least 3 years focused on medical device development.
• Demonstrated experience managing pre-clinical early feasibility and pivotal clinical studies.
• In-depth knowledge of regulatory requirements governing medical device clinical trials (FDA ISO 14155 (GCP) etc.).
• Project Management: Advanced organizational planning and prioritization skills; proficiency with project management tools and methodologies.
• Regulatory Acumen: Strong understanding of clinical research regulations and standards applicable to medical devices.

Nice to Have

• Proven track record of successful cross-functional project leadership in a regulated environment.
• Leadership: Ability to inspire influence and drive teams toward common goals.
• Communication: Excellent written and verbal communication skills; adept at presenting complex information to diverse audiences.
• Problem Solving: Proactive in identifying issues and developing effective solutions.
• Collaboration: Experience working with multidisciplinary teams and external partners.
• Attention to Detail: Commitment to accuracy and quality in all deliverables.

Additional Information :

Due to the nature of our business and the role please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19.  Details can vary by role.

Intuitive is an Equal Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees and prohibit discrimination and harassment of any type without regard to race sex pregnancy sexual orientation gender identity national origin color age religion protected veteran or disability status genetic information or any other status protected under federal state or local applicable laws.

Mandatory Notices

U.S. Export Controls Disclaimer:  In accordance with the U.S. Export Administration Regulations (15 CFR 743.13(b)) some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employeeswho are nationals from countries currently on embargo or sanctions status.

Certain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the governments licensing process can take 3 to 6 months) or (ii) implement a Technology Control Plan (TCP) (note: typically adds 2 weeks to the hiring process).  

For any Intuitive role subject to export controls final offers are contingent upon obtaining an approved export license and/or an executed TCP prior to the prospective employeesstart date which may or may not be flexible and within a timeframe that does not unreasonably impede the hiring need. If applicable candidates will be notified and instructed on any requirements for these purposes. 

We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.

Preference will be given to qualified candidates who do not reside or plan to reside in Alabama Arkansas Delaware Florida Indiana Iowa Louisiana Maryland Mississippi Missouri Oklahoma Pennsylvania South Carolina or Tennessee.

We provide market-competitive compensation packages inclusive of base pay incentives benefits and equity. It would not be typical for someone to be hired at the top end of range for the role as actual pay will be determined based on several factors including experience skills and qualifications. The target compensation ranges are listed.

Remote Work :

No

Employment Type :

Full-time