Experienced Director of Decentralized Clinical Trials – Remote Customer Support and Clinical Research Operations

At blithequark, we are committed to revolutionizing the way clinical trials are conducted, and we're looking for a highly skilled and experienced Director of Decentralized Clinical Trials to join our team. As a pioneer in the field of decentralized clinical trials, blithequark is dedicated to providing innovative and patient-centric solutions that transform the way clinical research is conducted.

About blithequark

blithequark is a leading healthcare company that is passionate about improving patient outcomes and advancing medical research. With a strong commitment to innovation and excellence, we are constantly pushing the boundaries of what is possible in the field of clinical trials. Our team of experts is dedicated to providing high-quality services that meet the evolving needs of our clients and patients.

Job Summary

We are seeking an experienced Director of Decentralized Clinical Trials to lead our decentralized clinical trials (DCT) team. As a key member of our clinical trials operations team, you will be responsible for the 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 blithequark'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 the selection and management of decentralized trial vendors, including the development of business requirements and management of UAT processes
• Oversee cross-functional colleagues 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 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 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 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
• Comprehensive benefits package, including health, dental, and vision insurance
• 401(k) retirement plan with company match
• Paid time off and holidays
• Professional development opportunities and training
• Collaborative and dynamic work environment

Requirements

* Bachelor's degree

• 5+ years of experience in clinical trials operations, preferably in a decentralized or hybrid trial setting
• Strong leadership and management skills, with experience leading cross-functional teams
• Excellent communication and interpersonal skills, with the ability to work effectively with internal and external stakeholders
• Ability to work independently and make timely, critical decisions
• Strong analytical and problem-solving skills, with the ability to analyze complex data and develop effective solutions
• Proficiency in Microsoft Office, including Excel, Word, and PowerPoint

How to Apply

If you are a motivated and experienced professional looking for a new challenge, we encourage you to apply for this exciting opportunity. Please submit your resume and a cover letter outlining your qualifications and experience. We look forward to hearing from you! Apply Now! Apply for this job