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About arenaflex
arenaflex is a forward-thinking healthcare innovation company dedicated to transforming the way clinical trials are designed, conducted, and delivered. As a leader in decentralized and hybrid clinical trial solutions, arenaflex is committed to making clinical research more accessible, efficient, and patient-centric. We believe that the future of medicine lies in breaking down traditional barriers to participation, enabling patients from all walks of life to contribute to groundbreaking research without the burden of frequent in-person visits. Our mission is to revolutionize clinical development by integrating cutting-edge technology, strategic partnerships, and patient-focused methodologies that accelerate the delivery of life-changing therapies to market.
At arenaflex, we pride ourselves on fostering a dynamic, collaborative, and inclusive work environment where innovation thrives and every team member has the opportunity to make a meaningful impact. Join us as we lead the charge in redefining clinical research and shaping the future of healthcare.
Position Overview
We are currently seeking an experienced and strategic-minded professional to join our Clinical Trials business as the Director of Decentralized Clinical Trials (DCT). This pivotal leadership role will be instrumental in developing and delivering arenaflex's decentralized and hybrid clinical trial services, ensuring we maintain our position at the forefront of clinical research innovation. The ideal candidate will possess a unique blend of clinical operations expertise, strategic vision, and leadership capabilities to drive the successful execution of complex clinical trials.
As the Director of Decentralized Clinical Trials, you will serve as a key leader within our DCT solutions offering and projects team, working closely with senior leadership to build and deliver flexible, efficient, and patient-friendly decentralized and hybrid trial programs. This role offers an exceptional opportunity to shape the future of clinical research at arenaflex while working with a talented team of professionals committed to advancing medical science.
Key Responsibilities
The Director of Decentralized Clinical Trials will be accountable for the following core responsibilities:
- Strategic Trial Leadership: Lead the successful development and execution of clinical trials, ensuring projects are delivered on time, within budget, in full compliance with regulatory requirements, and meeting the highest quality standards.
- Cross-Functional Team Management: Oversee cross-functional study teams throughout all phases of study development, operationalization, and delivery, ensuring seamless collaboration and alignment across all stakeholders.
- Strategic Planning Support: Assist the Head of Decentralized Clinical Trials in strategic planning, resourcing, and the operationalization of decentralized and hybrid trials, contributing to the overall growth and success of the DCT business unit.
- Vendor Management: Administer the selection and management of decentralized trial vendors, including the development of business requirements and management of User Acceptance Testing (UAT) processes to ensure vendor solutions meet organizational standards.
- Study Documentation Development: Lead cross-functional colleagues in the development of study documents and plans, including but not limited to protocols, Informed Consent Forms (ICF), Statistical Analysis Plans (SAP), Data Management Plans (DMP), and Safety Plan development.
- Team Leadership & Development: Select, train, manage, and coach DCT team members, fostering a culture of excellence, continuous learning, and professional growth.
- Product & Technology Collaboration: Collaborate with Product and Technology leadership to ensure that critical features for clients are launched on time and meet client needs and expectations.
- Trial Operations Oversight: Provide oversight for the conduct of remote clinical trial visits, site initiations, and study closeouts with client representatives, ensuring operational excellence throughout the trial lifecycle.
- Business Development Contribution: Participate in business development efforts, including proposal and budget development and bid defense processes to support revenue growth and client acquisition.
- SOP Development & Maintenance: Assist in the development and maintenance of appropriate Standard Operating Procedures (SOPs), plans, and policies related to DCTs to ensure consistent quality and compliance.
- Technical Input & Innovation: Provide input to the technical team for expanding capabilities to support evolving client needs and market trends in decentralized clinical research.
Essential Qualifications
To be considered for this role, candidates must possess the following required qualifications:
- Educational Background: Bachelor's Degree in a relevant scientific, healthcare, or business discipline is required. Advanced degrees (Master's, PhD, or equivalent) are preferred but not mandatory.
- Industry Experience: Prior experience in the pharmaceutical, biotechnology, or Contract Research Organization (CRO) sector with a proven track record of developing and driving DCT projects, including budget and scope development.
- DCT Vendor Experience: Knowledge of and experience managing decentralized trial vendors, with a thorough understanding of vendor selection, oversight, and performance management.
- Drug-Device Development Expertise: Deep understanding of the drug and device development process, with specific expertise in decentralized and hybrid clinical trials.
- Regulatory Knowledge: Outstanding working knowledge of International Council for Harmonisation (ICH) Good Clinical Practice (GCP) guidelines, United States Code of Federal Regulations (US CFR), and Health Insurance Portability and Accountability Act (HIPAA) regulations.
- Technical Proficiency: Familiarity with the skills and ability to apply new systems to regular tasks, with a strong aptitude for learning and adapting to evolving technologies.
- Scalability Mindset: Understanding the importance of scalability and the enthusiasm to learn and adapt to technology changes over time to support organizational growth.
- Leadership Capabilities: Strong leadership skills with demonstrated ability to lead both internal and external teams effectively, fostering collaboration and achieving results.
- Independent Decision-Making: Capacity to work independently and make appropriate strategic decisions to operationalize and advance clinical trial operations.
- Project Management: Ability to manage multiple projects simultaneously while maintaining strong attention to detail and quality.
- Prioritization & Time Management: Capacity to prioritize tasks and resources effectively, meet deadlines, and remain flexible to changing business needs and priorities.
- Communication Skills: Excellent written and oral communication skills, including strong presentation abilities to effectively engage with stakeholders at all levels.
- Travel Requirement: Willingness to travel up to 20% of the time for business purposes, including both intra-state and inter-state travel.
Preferred Qualifications
While the following qualifications are not required, they would be considered a strong advantage:
- Advanced degree in Life Sciences, Public Health, Business Administration, or a related field.
- Direct experience with patient recruitment and retention strategies in decentralized trial settings.
- Knowledge of telemedicine and digital health technologies used in clinical research.
- Experience with electronic clinical outcome assessments (eCOA) and wearable devices in clinical trials.
- Project Management Professional (PMP) certification or equivalent.
- Experience in a matrix organizational structure with cross-functional global teams.
Skills & Competencies Required for Success
Beyond formal qualifications, we are seeking a candidate who demonstrates the following key competencies:
- Strategic Thinking: Ability to think globally and develop long-term strategies that align with organizational objectives while responding to market dynamics.
- Innovation Mindset: A proactive approach to identifying opportunities for improvement and implementing innovative solutions in clinical trial design and operations.
- Stakeholder Management: Excellent interpersonal skills with the ability to build and maintain strong relationships with internal and external stakeholders, including clients, vendors, and regulatory authorities.
- Problem-Solving: Strong analytical and problem-solving skills with the ability to navigate complex challenges and develop practical, effective solutions.
- Adaptability: Comfortable operating in a fast-paced, evolving environment with changing priorities and requirements.
- Collaboration: Team-oriented approach with demonstrated ability to work effectively across functional boundaries and geographic locations.
- Results Orientation: Strong focus on delivering measurable outcomes and driving continuous improvement in trial performance metrics.
Career Growth & Learning Opportunities
At arenaflex, we are deeply invested in the professional development and career growth of our team members. As the Director of Decentralized Clinical Trials, you will have access to a range of learning and advancement opportunities, including:
- Leadership development programs designed to enhance your strategic capabilities and prepare you for greater responsibilities.
- Continuous training on emerging technologies, regulatory developments, and industry best practices in decentralized clinical research.
- Exposure to cutting-edge clinical trial methodologies and digital health innovations.
- Mentorship from senior leaders within the organization.
- Career advancement pathways into senior leadership positions within the Clinical Trials business unit.
- Participation in industry conferences, workshops, and professional networking events.
- Cross-functional exposure to other areas of the business, including product development, technology, and commercial operations.
Work Environment & Culture
arenaflex offers a vibrant and supportive work environment that values diversity, inclusion, and innovation. Our culture is built on collaboration, integrity, and a shared commitment to transforming clinical research. As part of our team, you will enjoy:
- Flexible work arrangements, including remote work options where applicable.
- A collaborative team atmosphere that encourages open communication and idea sharing.
- Access to state-of-the-art tools and technologies to support your work.
- A diverse and inclusive workplace where different perspectives are valued and celebrated.
- Regular team-building activities and social events.
- A supportive management team committed to employee well-being and success.
Compensation & Benefits
We offer a competitive compensation package commensurate with experience and qualifications. The expected hourly rate for this position ranges from $20 to $30 per hour, with opportunities for overtime and performance-based bonuses. In addition to competitive pay, arenaflex provides a comprehensive benefits package that includes:
- Health, dental, and vision insurance coverage.
- 401(k) retirement plan with company matching.
- Paid time off (PTO) and holidays.
- Life insurance and disability coverage.
- Employee assistance program (EAP) for personal and professional support.
- Professional development reimbursement.
- Wellness programs and resources.
- Relocation assistance for qualified candidates, if applicable.
Location
This position is based in New York, USA. We offer a hybrid work model that combines remote flexibility with periodic in-office collaboration. We are conveniently located in the heart of New York City, with easy access to public transportation and proximity to renowned healthcare and research institutions.
How to Apply
We invite qualified candidates who are passionate about advancing clinical research and making a meaningful impact on patient care to apply for this exciting opportunity. To be considered, please submit your updated resume and cover letter detailing your relevant experience and qualifications.
arenaflex is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We do not discriminate based on race, color, religion, national origin, sex, age, disability, genetic information, sexual orientation, gender identity, or any other protected characteristic.
Join Our Team
If you are ready to take the next step in your career and contribute to groundbreaking work that improves lives around the world, we encourage you to apply today. At arenaflex, you will find more than just a job—you will find a community of dedicated professionals who share your passion for innovation and commitment to excellence. Join us as we continue to transform the landscape of clinical research and bring life-changing therapies to patients everywhere.
We look forward to welcoming a talented and motivated professional to our team and are excited about the possibility of you contributing to our continued success.