Senior Project Manager - Clinical

Intuitive•Sunnyvale, CA

About The Position

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 initiative’s 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 bottom’s up schedules, identifying critical path, risk registers and conducting detailed project reviews to drive continuous improvement.

Requirements

Bachelor’s 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 Haves

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.

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 initiative’s 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.