At arenaflex, we're on a mission to revolutionize the way clinical trials are conducted, and we're looking for a highly skilled and experienced Director of Decentralized Clinical Trials RWE Clinical Trials to join our team. As a pioneer in the field of decentralized clinical trials, arenaflex is committed to providing innovative and patient-centric solutions that transform the way clinical research is conducted.
**About arenaflex**
arenaflex is a leading healthcare company that's dedicated to improving patient outcomes through innovative clinical trials and research. With a strong focus on decentralized clinical trials, arenaflex is at the forefront of a new era in clinical research, one that's driven by technology, data, and patient-centricity. Our team of experts is passionate about delivering high-quality clinical trials that meet the needs of patients, sponsors, and researchers alike.
**Job Summary**
We're seeking an experienced Director of Decentralized Clinical Trials RWE Clinical Trials to lead our decentralized clinical trials team. As a key member of our Clinical Trials business, you'll be responsible for developing and executing decentralized clinical trials that are efficient, effective, and patient-centric. You'll work closely with our Head of Decentralized Clinical Trials to develop and implement arenaflex's DCT services, ensuring that our trials are conducted to the highest standards of quality, safety, and regulatory compliance.
**Key Responsibilities**
As a Director of Decentralized Clinical Trials RWE Clinical Trials, you'll be responsible for:
* Developing and executing clinical trials that are efficient, effective, and patient-centric
* Managing cross-functional review teams during all phases of study development, operationalization, and delivery
* Collaborating with the Head of Decentralized Clinical Trials to develop and implement arenaflex's DCT services
* Administering the selection and management of decentralized trial vendors, including the development of business requirements and the management of UAT processes
* Overseeing the development of study documents and plans, including but not limited to: protocol, ICF, SAP, DMP, and Security plan development
* Selecting, training, managing, and coaching DCT colleagues
* Collaborating with Product and Innovation teams to ensure that key deliverables for clients are launched on time and meet client needs
* Providing oversight to the lead of remote clinical trial visits, site initiations, and study closures with client representatives
* Participating in business development efforts, including proposal and budget development and bid defense process
* Assisting with the development and maintenance of appropriate SOPs, plans, and procedures related to DCTs
* Contributing to the technical team to extend capabilities to support client needs
**Essential Capabilities**
To be successful in this role, you'll need:
* Past experience or CRO experience creating and driving DCT projects, including budget and scope development
* Knowledge of and experience managing DCT vendors
* In-depth understanding of the medical device development process, including decentralized and hybrid trials
* Strong working knowledge of ICH GCP, US CFR, and HIPAA regulations
* Educated with the skills and ability to apply new systems to routine tasks
* Understanding of the importance of adaptability and willingness 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 activities 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**
As a Director of Decentralized Clinical Trials RWE Clinical Trials at arenaflex, you'll enjoy a competitive salary range of $20-30/hour, as well as a range of benefits and perks, including:
* Flexible work arrangements, including remote work options
* Opportunities for professional growth and development
* Collaborative and dynamic work environment
* Recognition and rewards for outstanding performance
* Comprehensive benefits package, including medical, dental, and vision insurance
* 401(k) matching program
* Paid time off and holidays
**How to Apply**
If you're a motivated and experienced professional with a passion for decentralized clinical trials, we encourage you to apply for this exciting opportunity. Please submit your resume and a cover letter outlining your qualifications and experience. We can't wait to hear from you!
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