Experienced Director of Decentralized Clinical Trials RWE Clinical Trials – Remote Customer Support Jobs
At arenaflex, we are revolutionizing 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 is 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 the industry, providing cutting-edge solutions that are transforming the way clinical research is conducted. Our team of experts is passionate about delivering high-quality results that meet the needs of our clients and patients.
Job Summary
We are seeking an experienced Director of Decentralized Clinical Trials RWE Clinical Trials to lead our decentralized clinical trials team. As a key member of our team, you will 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 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.
Key Responsibilities
* Develop and execute clinical trials, including direct trials on time, on budget, in compliance, and of superior quality
- Manage cross-functional review teams during all stages of study development, operationalization, and delivery
- Assist the Head of Decentralized Clinical Trials in strategic planning, resourcing, and execution of decentralized and hybrid trials
- Administer selection and management of decentralized trial vendors, including development of business requirements and management of UAT process
- Oversee cross-functional colleagues in the development of study protocols and plans, including but not limited to: convention, ICF, SAP, DMP, and Security plan development
- Select, train, manage, and coach DCT colleagues; Collaborate with Product and Innovation initiative to ensure that key features for clients are launched on time and meet client needs
- Provide oversight to the lead of remote clinical trial visits, site initiations, and study closures with client delegates
- Participate in business development efforts, including proposal and budget development and bid defense process
- Assist in the development and maintenance of appropriate SOPs, plans, and procedures related to DCTs
- Provide contribution to technical teams 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 pharmaceutical device development process, including decentralized and hybrid trials
- Excellent 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 flexibility and willingness to learn and adapt 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
- Willingness to travel up to 20% of the ideal time for business purposes within state and out of state
What We Offer
* Competitive salary range of $20-30/hour
- Opportunity to work with a leading healthcare company that is transforming the way clinical research is conducted
- Collaborative and dynamic work environment with a team of experts who are passionate about delivering high-quality results
- Opportunities for career growth and professional development
- Comprehensive benefits package, including health insurance, retirement plan, and paid time off
- Flexible work arrangements, including remote work options
How to Apply
If you are a motivated and experienced professional who is passionate about decentralized clinical trials, we encourage you to apply for this exciting opportunity. Please submit your resume and cover letter to [insert contact information]. We look forward to hearing from you!
Equal Employment Opportunity
arenaflex is an equal employment opportunity employer and welcomes applications from diverse candidates. We are committed to creating an inclusive and diverse work environment that values and respects the contributions of all employees.
Note
arenaflex is a leading healthcare company that is 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 the industry, providing cutting-edge solutions that are transforming the way clinical research is conducted. Apply for this job