Experienced Director of Decentralized Clinical Trials RWE Clinical Trials – Part Time Remote Customer Support Role at arenaflex
Job Summary:
arenaflex is a leading healthcare organization dedicated to delivering innovative solutions in decentralized clinical trials. We are seeking an experienced Director of Decentralized Clinical Trials RWE Clinical Trials to join our team in a part-time remote customer support role. As a key member of our DCT arrangements offering and tasks group, you will work closely with the Head of Decentralized Clinical Trials to develop and implement arenaflex's DCT services, building and delivering adaptable, efficient, and patient-friendly hybrid and decentralized trials.
About arenaflex:
arenaflex is a pioneering healthcare organization that has been at the forefront of decentralized clinical trials for years. Our mission is to revolutionize the way clinical trials are conducted, making them more efficient, patient-friendly, and cost-effective. We are committed to delivering innovative solutions that meet the evolving needs of our clients and patients. Our team of experts is passionate about making a difference in the lives of patients and is dedicated to excellence in everything we do.
Job Responsibilities:
As a Director of Decentralized Clinical Trials RWE Clinical Trials, you will be responsible for the successful development and execution of clinical trials, including direct trials on time, on budget, in compliance, and of superior quality. Your key responsibilities will include:
- Supervising cross-functional review teams during all stages of study development, operationalization, and delivery
- Assisting the Head of Decentralized Clinical Trials in strategic planning, resourcing, and execution of decentralized and hybrid trials
- Administering the selection and management of decentralized trial vendors, including the development of business requirements and UAT process management
- Overseeing cross-functional colleagues in the development of study reports and plans, including but not limited to: protocol, ICF, SAP, DMP, and Security plan development
- Recruiting, training, managing, and coaching DCT colleagues; Collaborating with Product and Innovation leaders to ensure that key features for patients are launched on time and meet patient needs
- Providing oversight to the conduct of remote clinical trial visits, site initiations, and study closures with client agents
- Participating in business development efforts, including proposal and budget development and bid defense process
- Assisting in the development and support of appropriate SOPs, plans, and strategies related to DCTs
- Contributing 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
- In-depth understanding of the pharmaceutical product development process, including decentralized and hybrid trials
- Outstanding working knowledge of ICH GCP, US CFR, and HIPAA regulations
- Educated with the skills and ability to apply new frameworks to routine tasks
- Understand the importance of adaptability and enthusiasm 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 suitable critical decisions to operationalize and move clinical trial initiatives forward
- Ability to direct multiple projects simultaneously, while maintaining precision
- Ability to focus on tasks and resources, meet time constraints, and be flexible to changing needs
- Excellent written and oral communication and presentation skills
- At least 2 years of experience contributing to financial decisions in the workplace
- At least 2 years of direct leadership, aberrant management, or cross-functional team leadership
- Able to travel up to 20% of the ideal time for business purposes within state and out of state
Work Environment and Company Culture:
arenaflex is a dynamic and innovative organization that values diversity, equity, and inclusion. We offer a collaborative and supportive work environment that fosters growth, learning, and creativity. Our team is passionate about making a difference in the lives of patients and is dedicated to excellence in everything we do. We offer a competitive salary, comprehensive benefits package, and opportunities for career growth and development.
Compensation, Perks, and Benefits:
arenaflex offers a competitive salary of $26/hour, comprehensive benefits package, and opportunities for career growth and development. We also offer a range of perks and benefits, including:
- Flexible work arrangements, including remote work options
- Comprehensive health insurance, including medical, dental, and vision coverage
- 401(k) retirement plan with company match
- Paid time off, including vacation, sick leave, and holidays
- Professional development opportunities, including training, education, and certification programs
- Collaborative and supportive work environment
- Opportunities for career growth and advancement
How to Apply:
If you are a motivated and experienced professional looking for a challenging and rewarding role, we encourage you to apply. Please submit your resume and cover letter to [insert contact information]. We look forward to hearing from you!
Note:
arenaflex is an equal opportunity employer and welcomes applications from diverse candidates. We are committed to creating an inclusive and respectful work environment that values diversity, equity, and inclusion. Apply for this job