Sr. Project Manager, Clinical Affairs

Intuitive•Sunnyvale, CA

About The Position

The Senior Project Manager, Clinical Affairs, plays a pivotal role in supporting Clinical Affairs activities by partnering with key functions and business units across the organization, including R&D, Regulatory Affairs (RA), Clinical Development Engineering, Quality, and Business Unit PMOs. This role brings disciplined structure, cross-functional coordination, and strategic oversight to high-priority clinical affairs initiatives. Responsibilities include providing project management support and cross-functional coordination—within Clinical Affairs and with enterprise stakeholders—through the planning and execution of clinical studies (e.g., FHUs and IDE studies) and coordinating Clinical Evaluations to support MDR and other global submissions. The Senior Project Manager is accountable for building and sustaining effective collaboration across stakeholders to ensure Clinical Affairs deliverables are completed successfully and on time. An ideal candidate brings deep familiarity with medical device development lifecycle as well as clinical lifecycle management, providing tactical guidance for execution frameworks that translate Clinical Affairs objectives into actionable plans, including development roadmaps, governance forums, prioritization, and alignment with business units and other key stakeholders. The role also requires hands-on management of project risks, troubleshooting execution challenges, coordinating internal and external activities, and ensuring milestones are achieved on time and within scope. Examples include developing bottom-up schedules, identifying critical path activities, maintaining risk registers, and leading detailed project reviews to drive continuous improvement. Additionally, this role supports development of Clinical Affairs tools and operating mechanisms, including project dashboards, capacity and resource planning, and other processes needed to improve visibility, planning, and execution across the function.

Requirements

Bachelor’s degree in Life Sciences, Engineering, or a related field.
Minimum of 5 years’ experience in clinical project management, with at least 3 years focused on medical device development.
Experience acting as a liaison between clinical and technical/project management teams.
Knowledgeable with all stages of clinical studies, design control process, product development lifecycle; including idea generation, concept development and testing, design, implementation, validation and transfer.
Advanced organizational, planning, and prioritization skills; proficiency with project management tools such as Smartsheet, MS Project, or equivalent and methodologies.
Strong understanding of clinical research regulations and standards applicable to medical devices.
Familiarity with global regulatory requirements (e.g., FDA, EU MDR, ISO 14155, ICH GCP).

Nice To Haves

Certification in project management (PMP) desired.
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 project planning, initiation of Clinical Affairs activities across clinical studies and clinical dossier deliverables, ensuring alignment to program milestones and regulatory expectations.
Develop and maintain integrated project plans that define scope, timelines, dependencies, resourcing, and deliverables for key Clinical Affairs workstreams.
Partner with cross-functional teams (R&D, Regulatory, Business Units, Clinical Development Engineering, Quality, and PMO) to align dependencies to support Clinical Affairs deliverables to the broader product development lifecycle.
Track progress against milestones for clinical trials and global clinical dossier submissions (e.g., EU Clinical Evaluation Reports [CERs]), including metric reporting and portfolio status summaries.
Facilitate routine cross-functional meetings; provide clear status updates, document decisions, and capture/drive action items to closure.
Coordinate activities within clinical affairs with subfunctions such as clinical operation, Clinical Data Management, Biostatistics, and Medical Sciences to ensure timely, consistent execution of study and submission deliverables.
Create and maintain tracking tools (dashboards, action logs, and schedules) to monitor study/submission progress, highlight risks and dependencies, and support proactive decision-making.
Support budget and timeline adherence by identifying resource constraints early, escalating as needed, and driving mitigation plans with functional leads.
Develop and deliver clear, audience-appropriate communications (project updates, decisions, risks, and next steps) to Clinical Affairs leadership and cross-functional stakeholders.
Prepare executive-ready status materials (dashboards, RAG status, milestone summaries, and key metrics) and ensure reporting cadence is maintained.
Serve as the primary point of contact and liaison between Clinical Affairs and key collaborative functions as well as cross-functional working groups to drive alignment and resolve conflicts.
Facilitate governance forums and working sessions by setting agendas, capturing decisions, and driving alignment across functions and business units.
Manage escalation pathways by surfacing critical issues early, aligning recommended options, and coordinating timely resolution.
Maintain high-quality project documentation, including action logs, decision logs, meeting notes, and communication artifacts, to support traceability and continuity.
Proactively identify execution risks, issues, and gaps; develop mitigation plans; and escalate priority items to leadership with recommended options.
Promote consistency across multiple clinical projects/programs by applying standard project management practices (scope, schedule, risk/issue management, and change control as appropriate).
Drive continuous improvement of Clinical Affairs project management processes and best practices, with a focus on cross-functional collaboration and operational efficiency.