Director, Decentralized Clinical Trials – Real‑World Evidence (RWE) – Part‑Time Remote – $26/hr – arenaflex

About arenaflex – Pioneering the Future of Decentralized Clinical Research

arenaflex is a global leader in innovative health‑care solutions, dedicated to transforming how clinical trials are designed, executed, and delivered. With a strong focus on real‑world evidence (RWE) and decentralized clinical trial (DCT) methodologies, arenaflex empowers researchers, sponsors, and patients to collaborate across borders, time zones, and technology platforms. Our mission is to accelerate the development of safe, effective therapies while improving patient access and experience. As a remote‑first organization, arenaflex embraces flexibility, diversity, and a culture of continuous learning.

Position Overview

arenaflex is seeking a visionary and results‑driven Director of Decentralized Clinical Trials (RWE) to join our Remote Clinical Operations team on a part‑time basis (approximately 8 hours per week). This senior role will serve as a strategic catalyst for the design, implementation, and oversight of hybrid and fully decentralized trial programs. Reporting directly to the Head of Decentralized Clinical Operations, you will lead cross‑functional teams, manage external vendors, and ensure that every study is delivered on time, within budget, and to the highest quality standards.

Key Responsibilities

• Strategic Planning & Execution: Develop and execute end‑to‑end DCT strategies that align with arenaflex’s RWE objectives, ensuring studies are patient‑centric, cost‑effective, and compliant.
• Project Leadership: Own the full lifecycle of decentralized clinical studies—including protocol development, site initiation, remote monitoring, data capture, and study close‑out.
• Cross‑Functional Collaboration: Partner with Clinical Operations, Data Management, Biostatistics, Regulatory Affairs, and Product Innovation teams to integrate decentralized components seamlessly into overall trial designs.
• Vendor Management: Identify, negotiate, and oversee DCT service providers (e‑consent platforms, telehealth vendors, home‑health nursing, logistics partners), driving performance through clear KPIs and service‑level agreements.
• Regulatory & Compliance Oversight: Ensure all decentralized activities adhere to ICH GCP, US CFR, HIPAA, and other relevant regulations, maintaining rigorous documentation and audit readiness.
• Training & Mentorship: Recruit, onboard, and coach DCT staff and investigators, fostering a culture of innovation, quality, and continuous improvement.
• Budget & Financial Stewardship: Manage study budgets, forecast resource needs, and identify cost‑saving opportunities without compromising scientific integrity.
• Stakeholder Communication: Provide regular updates to senior leadership, sponsors, and external partners, translating complex technical concepts into clear, actionable insights.
• Process Optimization: Lead the development and refinement of SOPs, work instructions, and best‑practice guides specific to decentralized trial execution.
• Business Development Support: Contribute to proposal development, pricing strategy, and bid defense activities for new DCT opportunities.

Essential Qualifications

• Bachelor’s degree in Life Sciences, Pharmacy, Nursing, Health‑Information Management, or a related field. Advanced degree (MS, MPH, PhD) is highly desirable.
• Minimum of 2 years of hands‑on experience managing decentralized or hybrid clinical trials, preferably within a CRO, pharmaceutical company, or academic research setting.
• Demonstrated expertise in budgeting, resource planning, and financial management of clinical projects.
• Strong knowledge of DCT vendor ecosystems, including e‑consent, remote monitoring, and home‑based data collection technologies.
• In‑depth understanding of ICH GCP, US CFR, HIPAA, and other regulatory frameworks governing clinical research.
• Proven ability to lead multi‑disciplinary teams, both internally and across external partners, to achieve project milestones.
• Excellent written and verbal communication skills, with the ability to present complex information to diverse audiences.
• Willingness to travel up to 20 % of the time for site visits, sponsor meetings, or industry conferences (travel may be domestic or international).

Preferred Qualifications & Additional Skills

• Master’s degree or higher in a relevant scientific discipline.
• Experience with real‑world evidence generation, observational studies, or pragmatic trial designs.
• Familiarity with digital health tools, wearable devices, and mobile app data integration.
• Certification in Project Management (PMP, PRINCE2) or Clinical Research (CCRP, ACRP).
• Track record of publishing or presenting DCT outcomes at scientific conferences.
• Ability to adapt quickly to emerging technologies and evolving regulatory landscapes.

Core Competencies for Success

• Strategic Thinking: Ability to envision and operationalize innovative trial models that balance scientific rigor with patient convenience.
• Analytical Acumen: Strong data‑driven mindset; comfortable interpreting trial metrics, risk assessments, and financial forecasts.
• Leadership & Influence: Demonstrated capacity to inspire, motivate, and guide teams through complex, ambiguous environments.
• Problem‑Solving: Proactive approach to identifying obstacles and implementing effective, scalable solutions.
• Collaboration: Skilled at building strong relationships with internal stakeholders, external vendors, and regulatory bodies.
• Adaptability: Comfortable navigating rapid change, technology adoption, and evolving industry standards.

Career Growth & Learning Opportunities at arenaflex

arenaflex invests heavily in the professional development of its employees. As a Director of Decentralized Clinical Trials, you will have access to:

• Mentorship from senior leaders in global clinical research and RWE strategy.
• Funding for certifications, conferences, and advanced training in digital health, data science, and regulatory affairs.
• Opportunities to lead high‑visibility, cross‑border projects that shape the future of clinical trial innovation.
• Pathways to senior executive roles such as Vice President of Clinical Operations or Global Head of Decentralized Trials.

Work Environment & Culture at arenaflex

arenaflex champions a remote‑first, inclusive, and collaborative culture. Our employees enjoy:

• Flexible work schedules that respect work‑life balance, especially important for part‑time team members.
• A diverse, global community where ideas are judged on merit, not geography.
• Regular virtual “coffee chats,” team‑building events, and knowledge‑sharing sessions.
• State‑of‑the‑art collaboration tools, secure data platforms, and a robust IT support system.
• Commitment to employee well‑being through mental‑health resources, wellness stipends, and ergonomic home‑office allowances.

Compensation, Perks & Benefits

arenaflex offers a competitive hourly rate of $26 per hour, reflective of the expertise required for this senior role. In addition to base compensation, part‑time employees may receive:

• Performance‑based bonuses tied to project milestones and quality metrics.
• Access to a comprehensive health‑care package (medical, dental, vision) on a prorated basis.
• Retirement savings options with employer matching contributions.
• Paid time off and sick leave, accrued proportionally to hours worked.
• Professional development budget for courses, certifications, and industry conferences.
• Technology stipend for home‑office equipment and high‑speed internet connectivity.

How to Apply

If you are passionate about reshaping clinical research, thrive in a remote environment, and possess the strategic vision to lead decentralized trials, we want to hear from you. Join arenaflex and be part of a forward‑thinking team that is redefining the future of health‑care innovation.

Apply Now and start your journey with arenaflex today!