Experienced Director, Decentralized Clinical Trials RWE Clinical Trials – Remote Work Opportunity at careerzynith
At careerzynith, we're revolutionizing the way clinical trials are conducted, and we're looking for a seasoned professional to join our team as a Director, Decentralized Clinical Trials RWE Clinical Trials. As a pioneer in decentralized clinical trials, careerzynith is committed to providing innovative, efficient, and patient-centric solutions that transform the clinical research landscape.
**About careerzynith**
careerzynith is a leading healthcare company that's dedicated to improving patient outcomes through cutting-edge clinical trials and research. With a strong focus on decentralized clinical trials, we're at the forefront of a new era in clinical research, where patients, researchers, and healthcare professionals come together to drive innovation and progress.
**Job Summary**
As a Director, Decentralized Clinical Trials RWE Clinical Trials, you'll play a critical role in leading our decentralized clinical trials team, working closely with the Head of Decentralized Clinical Trials to develop and implement careerzynith's DCT services. You'll be responsible for managing cross-functional review groups, overseeing the development and execution of clinical trials, and ensuring that all trials are conducted on time, on budget, and with the highest level of quality.
**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 phases of study development, operationalization, and delivery
* Collaborate with the Head of Decentralized Clinical Trials to develop and implement careerzynith's DCT services
* Oversee the selection and management of decentralized trial vendors, including the development of business requirements and UAT process management
* Lead cross-functional teams in 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 in the development and maintenance of appropriate SOPs, plans, and procedures related to DCTs
* Contribute 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 medical 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 systems to routine tasks
* Understand the importance of adaptability and willingness to learn and adjust to technology changes over time
* Strong leadership abilities with demonstrated capacity 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
**Ready to make a trip up to 20 percent of the ideal opportunity for business purposes inside state and out of state.**
**What We Offer**
* Competitive salary range of $20-30/hour
* Opportunity to work with a leading healthcare company that's revolutionizing the clinical trials industry
* Collaborative and dynamic work environment with a team of experienced professionals
* 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're a motivated and experienced professional looking for a new challenge, we encourage you to apply for this exciting opportunity. Please submit your resume and cover letter to [careerzynith careers page](https://www.careerzynith.com/careers).
**Note:** careerzynith is an equal opportunity employer and welcomes applications from diverse candidates. We are committed to creating an inclusive and supportive work environment that values diversity, equity, and inclusion.
Apply for this job
**About careerzynith**
careerzynith is a leading healthcare company that's dedicated to improving patient outcomes through cutting-edge clinical trials and research. With a strong focus on decentralized clinical trials, we're at the forefront of a new era in clinical research, where patients, researchers, and healthcare professionals come together to drive innovation and progress.
**Job Summary**
As a Director, Decentralized Clinical Trials RWE Clinical Trials, you'll play a critical role in leading our decentralized clinical trials team, working closely with the Head of Decentralized Clinical Trials to develop and implement careerzynith's DCT services. You'll be responsible for managing cross-functional review groups, overseeing the development and execution of clinical trials, and ensuring that all trials are conducted on time, on budget, and with the highest level of quality.
**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 phases of study development, operationalization, and delivery
* Collaborate with the Head of Decentralized Clinical Trials to develop and implement careerzynith's DCT services
* Oversee the selection and management of decentralized trial vendors, including the development of business requirements and UAT process management
* Lead cross-functional teams in 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 in the development and maintenance of appropriate SOPs, plans, and procedures related to DCTs
* Contribute 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 medical 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 systems to routine tasks
* Understand the importance of adaptability and willingness to learn and adjust to technology changes over time
* Strong leadership abilities with demonstrated capacity 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
**Ready to make a trip up to 20 percent of the ideal opportunity for business purposes inside state and out of state.**
**What We Offer**
* Competitive salary range of $20-30/hour
* Opportunity to work with a leading healthcare company that's revolutionizing the clinical trials industry
* Collaborative and dynamic work environment with a team of experienced professionals
* 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're a motivated and experienced professional looking for a new challenge, we encourage you to apply for this exciting opportunity. Please submit your resume and cover letter to [careerzynith careers page](https://www.careerzynith.com/careers).
**Note:** careerzynith is an equal opportunity employer and welcomes applications from diverse candidates. We are committed to creating an inclusive and supportive work environment that values diversity, equity, and inclusion.
Apply for this job