At arenaflex, we're revolutionizing the way clinical trials are conducted, and we're looking for a seasoned professional to join our team as a Director of Decentralized Clinical Trials RWE Clinical Trials. As a pioneer in our Decentralized Clinical Trials (DCT) arrangements and tasks group, you'll work closely with our Head of Decentralized Clinical Trials to develop and deliver adaptable, efficient, and patient-friendly mixture and decentralized clinical trials.
**About arenaflex**
arenaflex is a leading healthcare company that's committed to improving patient outcomes through innovative clinical trials. With a strong focus on decentralized clinical trials, we're pushing the boundaries of what's possible in the industry. Our team is passionate about delivering high-quality results, and we're looking for like-minded individuals to join us on this exciting journey.
**Job Summary**
As a Director of Decentralized Clinical Trials RWE Clinical Trials, you'll be responsible for the effective development and execution of clinical trials, including direct trials on time, on budget, in compliance, and of superior quality. You'll work closely with cross-functional review groups during all stages of study development, operationalization, and delivery. Your expertise will be essential in helping our Head of Decentralized Clinical Trials with strategic planning, resourcing, and execution of decentralized and hybrid clinical trials.
**Key Responsibilities**
* Develop and execute clinical trials, including direct trials on time, on budget, in compliance, and of superior quality
* Manage cross-functional review groups during all stages of study development, operationalization, and delivery
* Assist the Head of Decentralized Clinical Trials with strategic planning, resourcing, and execution of decentralized and hybrid clinical trials
* Administer the selection and management of decentralized clinical trial vendors, including the development of business requirements and UAT process management
* Oversee the development of study documents and plans, including but not limited to: protocol, ICF, SAP, DMP, and Security plan development
* Select, train, manage, and coach DCT colleagues; Collaborate with Product and Innovation initiatives to ensure that key features for patients are launched on time and meet patient needs
* Provide oversight to the lead of remote clinical trial visits, site initiations, and study closures with client representatives
* Participate in business development efforts, including proposal and budget development and bid defense process
* Assist with the development and maintenance of appropriate SOPs, plans, and procedures related to DCTs
* Contribute to the technical team to extend capabilities to support client needs
**Essential Capabilities**
* Past experience or CRO experience creating and driving DCT projects, including budget and scope development
* Knowledge of and experience managing DCT vendors
* Deep understanding of the medical device development process, including decentralized and hybrid clinical trials
* Excellent working knowledge of ICH GCP, US CFR, and HIPAA regulations
* Educated with the skills and ability to apply new systems to routine tasks
* Understand the importance of adaptability and energy to learn and adjust to technology changes over time
* Strong leadership skills with demonstrated ability to lead internal and external teams
* Ability to work independently and make timely, critical decisions to operationalize and move clinical trial projects forward
* Ability to manage multiple tasks simultaneously, while maintaining attention to detail
* Ability to focus on tasks and resources, comply with time constraints, and be flexible to changing needs
* Excellent written and oral communication and presentation skills
**What We Offer**
* Competitive salary range of $20-30/hour
* Opportunity to work remotely from home
* Flexible work hours with up to 20% travel required for business purposes
* Comprehensive benefits package, including health, dental, and vision insurance
* 401(k) matching program
* Paid time off and holidays
* Professional development opportunities and training
* Collaborative and dynamic work environment
**How to Apply**
If you're a motivated and experienced professional looking to join a dynamic team, please submit your application through our website. We can't wait to hear from you!