Key Responsibilities and Required Skills for Xenon Program Specialist

🎯 Role Definition

The Xenon Program Specialist is a hands-on program operations and coordination expert responsible for planning, executing, and optimizing the Xenon program portfolio. This role partners with cross-functional stakeholders (clinical, regulatory, product, vendor, and commercial teams) to ensure timely deliverables, regulatory compliance, high-quality data, and efficient resource use. The Specialist balances day-to-day program logistics with continuous improvement of processes, SOPs, and performance metrics to enable scalable program delivery.

📈 Career Progression

Typical Career Path

Entry Point From:

Clinical Research Coordinator / Clinical Trial Associate with experience in device or gas-based studies
Program Coordinator or Project Coordinator in life sciences, medical devices, or healthcare services
Regulatory Affairs Associate or Quality Assurance Technician supporting early-phase programs

Advancement To:

Program Manager / Senior Program Specialist overseeing multi-site or multi-product Xenon initiatives
Clinical Operations Manager or Head of Program Delivery for a product line
Cross-functional Product Operations Lead or Portfolio Manager

Lateral Moves:

Regulatory Affairs Specialist focusing on device and gas-related filings (FDA/EMA)
Quality Systems Analyst or Continuous Improvement Lead for clinical operations

Core Responsibilities

Primary Functions

Lead end-to-end coordination of Xenon program activities, including project planning, milestone tracking, resource allocation, and cross-functional communication to ensure programs meet scope, budget, and timeline objectives.
Develop and maintain comprehensive program plans, Gantt charts, and risk registers for each Xenon initiative, proactively identifying interdependencies and mitigation strategies to keep projects on schedule.
Serve as the primary point of contact for internal and external stakeholders, coordinating weekly status meetings, preparing agendas and minutes, and escalating program-level risks to senior leadership with recommended actions.
Manage vendor and CRO relationships for device handling, gas supply, logistics, and study support by negotiating scopes of work, tracking deliverables, reviewing invoices, and enforcing contractual SLAs.
Draft, review, and maintain program documentation including SOPs, work instructions, training materials, study manuals, and regulatory submission packages to ensure consistency and audit readiness.
Oversee site and supply chain logistics for Xenon product distribution, inventory management, cold-chain or specialized handling requirements, and equipment deployment for clinical or commercial activities.
Coordinate regulatory interactions by assembling submission-ready documents, preparing regulatory trackers, supporting responses to agency queries, and ensuring program activities align with applicable FDA/EMA and local health authority regulations.
Monitor program budgets and financial performance: estimate costs, track actual spend against forecasts, prepare budget variance reports, and recommend corrective actions to maintain financial control.
Design and implement program-level KPIs and dashboards (e.g., on-time milestones, enrollment metrics, quality events) using Excel, Tableau, or other BI tools to provide actionable insights to program leadership.
Support clinical operations with patient recruitment strategies, site selection and initiation, investigator training, monitoring plans, and oversight of adverse event reporting processes specific to Xenon-related studies.
Coordinate data collection and quality assurance activities, including CRF/EDC design reviews, data reconciliation, query resolution, data cleaning cycles, and handoffs to biostatistics or data management teams.
Lead cross-functional change control and deviation management processes, documenting root cause analyses, corrective and preventive actions (CAPAs), and tracking closure to prevent recurrence.
Facilitate pilot studies, feasibility assessments, and operational readiness exercises prior to large-scale program rollouts, capturing lessons learned and operational checklists for future deployments.
Conduct risk assessments and contingency planning for supply interruptions, regulatory delays, site noncompliance, or technical failures, and execute mitigation plans in collaboration with stakeholders.
Manage training programs for clinical sites, field teams, and internal stakeholders on Xenon handling, safety protocols, device operation, and program procedures, and maintain training logs to demonstrate compliance.
Coordinate internal audits and external inspections support, prepare audit deliverables, respond to findings with documented corrective actions, and implement continuous improvement activities to raise program quality standards.
Prepare and deliver program-level communications, executive summaries, and briefing materials for steering committees and senior leadership to enable data-driven decision-making.
Lead product lifecycle activities related to Xenon program expansions, transitions from pilot to scale, and process standardization to support commercialization and market access readiness.
Support product safety surveillance and pharmacovigilance activities by triaging safety reports, coordinating with medical affairs and safety teams, and ensuring timely reporting to regulators when required.
Drive process improvement initiatives using lean or Six Sigma principles to reduce cycle times, eliminate waste in program workflows, and improve overall program throughput and quality.
Coordinate technical troubleshooting for equipment or supply issues in the field, working with engineering, manufacturing, and vendors to diagnose root cause and implement corrective actions.
Implement and maintain program-level documentation control and knowledge management systems to ensure version control, easy retrieval, and continuity across program phases.

Secondary Functions

Support ad-hoc data requests and exploratory data analysis.
Contribute to the organization's data strategy and roadmap.
Collaborate with business units to translate data needs into engineering requirements.
Participate in sprint planning and agile ceremonies within the data engineering team.
Assist commercial teams with launch readiness checklists, promotional material reviews, and field engagement planning to ensure aligned program rollouts.
Provide subject-matter support for insurance, reimbursement, and health-economics discovery efforts related to Xenon therapies or devices.
Maintain metrics and reporting for post-market surveillance or product performance monitoring in clinical and real-world settings.
Mentor junior program staff and provide onboarding support for new hires assigned to the Xenon program.

Required Skills & Competencies

Hard Skills (Technical)

Program and Project Management: demonstrated ability to manage multi-stream projects, create project plans, and drive cross-functional delivery (experience with MS Project, Smartsheet, or equivalent).
Clinical Operations & Trial Coordination: experience with site startup, monitoring, safety reporting, and site compliance specific to device/gas-based clinical studies.
Regulatory Knowledge: working knowledge of FDA/EMA submission processes, IDE/510(k) considerations (if applicable), GCP, and local regulatory requirements.
Quality Systems & CAPA Management: experience writing SOPs, deviation reports, CAPAs, and supporting audits and inspections.
Data Management & Reporting: competency with EDC systems, CRF design input, data cleaning workflows, and dashboarding tools (Excel, SQL, Tableau/Power BI).
Vendor/CRO Management: experience preparing SOWs, RFP evaluation, performance monitoring, and invoice reconciliation.
Budgeting & Financial Tracking: ability to develop budgets, perform variance analysis, and implement cost controls.
Risk Management: maintain and update risk registers, perform root cause analysis, and build mitigation plans.
Technical Documentation: strong technical writing skills for protocols, manuals, training materials, and regulatory documents.
Supply Chain & Logistics: knowledge of inventory control, cold-chain/logistics requirements, and vendor coordination for specialized supplies.
Safety & Pharmacovigilance Support: understanding of adverse event triage and reporting workflows (for clinical or post-market settings).
Tools & Systems: proficiency with Microsoft Office suite, project management tools (Asana/Jira), and collaboration platforms (Confluence/SharePoint).

Soft Skills

Strong written and verbal communication; ability to craft executive-level briefings and detailed operational documentation.
Stakeholder engagement and diplomacy; experience aligning competing priorities across clinical, regulatory, product, and commercial teams.
Problem solving and analytical thinking; able to synthesize complex program data and recommend pragmatic actions.
Attention to detail and quality-oriented mindset to support audit-ready program documentation.
Time management and prioritization; comfortable managing multiple concurrent projects with shifting priorities.
Leadership and influence without direct authority; ability to drive cross-functional teams to results.
Adaptability and resilience in fast-paced, regulated environments.
Teaching and coaching skills to train sites and junior staff on technical and procedural topics.

Education & Experience

Educational Background

Minimum Education:

Bachelor’s degree in Life Sciences, Healthcare Administration, Biomedical Engineering, Public Health, Business, or related field.

Preferred Education:

Master’s degree (MPH, MS, MBA) or advanced certification in clinical research, regulatory affairs, or project management (e.g., PMP, PMI-ACP).

Relevant Fields of Study:

Clinical Research or Nursing
Biomedical Engineering or Life Sciences
Regulatory Affairs or Health Policy
Business Administration / Project Management
Public Health or Epidemiology

Experience Requirements

Typical Experience Range:

3–7 years of progressive experience in program coordination, clinical operations, or program management within medical devices, pharmaceuticals, or specialized gas therapies.

Preferred:

5+ years managing multi-disciplinary programs with direct exposure to regulatory submissions, vendor/CRO oversight, and budget management; prior experience with xenon-related products, gas-handling logistics, or device-based clinical programs is highly desirable.