Overview
Lightship is the virtual-first provider that is perfecting the way clinical trials get done. Because clinical research plays such a vital role in bringing life-enhancing and lifesaving innovations to market, Lightship pursues operational excellence in clinical
studies. Our end-to-end hybrid delivery model, our diversity of skillsets, and in-house care team ensure sponsor success and the best possible patient experience.
With a problem-solving mindset, we strive to make every clinical trial better than the last. Operational excellence is not a goal, but a way of doing things at Lightship.
The Director, Quality is an individual with experience in establishing processes associated with executing clinical trials. This individual is expected to apply a systems thinking approach via a strong background in and history of successfully building and maintaining efficient quality systems. The Director, Quality works in a pivotal role collaborating with technology and clinical study personnel establishing the quality management systems applicable across all Lightship’s clinical trials.
This position is remote, and a successful candidate will possess a willingness and desire to work independently without significant oversight. Additionally, this position may require some travel.
The Director, Quality is responsible for:
- Under the direction of the Chief Business Officer, establishing the comprehensive quality management system for clinical trials at Lightship
- Participating in establishing various operational processes for clinical trials, including informed consent, investigator oversight, documentation, etc.
- Leading efforts to author and revise SOPs
- Proactively reviewing policies, Standard Operating Procedures (SOPs), training documents, etc. and providing input related to sound business processes and compliance matters
- Lead and / or participant in Quality Management Reviews (QMRs)
- In collaboration with clinical operations personnel, establishing key performance indicators (KPIs) for clinical trials
- Providing business process ownership for computerized systems as part of Lightship’s overall quality management system
- Providing advice and consultation to other departments on matters related to compliance for ongoing trials; participating in trial team meetings as requested
- Oversee the process owner for controlled documents across Lightship
- Leading clinical trial risk management activities, including proactively identifying and mitigating study risks through risk analysis tools
- Establishing efficient quality oversight mechanisms for ongoing trials; providing feedback and assistance in resolving operational problems
- Providing oversight for a portfolio of ongoing trials
- Leading vendor audits on behalf of the company
- Hosting and / or participating in client audits and regulatory inspections as a subject matter expert and / or running the “war room” as required
- Identifying areas for continuous improvement, defining improvement processes, and implementing them
- Providing training in various Good Clinical Practice (GCP) topics
- Researching compliance and regulatory topics, synthesizing the research, and developing relevant materials addressing and / or using the research
- Managing direct reports
- Other duties as assigned
Director, Quality has:
- Required knowledge, skills, and abilities
- Good understanding of GCP and clinical trial operations
- Good understanding of quality management practices in a clinical trial setting
- Strong written and verbal communication skills
- Strong attention to detail
- Strong organizational skills
- Excellent ability to assess risk
- Sound judgment
- Ability to collaborate effectively with various cross functional groups within the company
- Education and experience
- Bachelor’s degree in Life Sciences, Engineering, Computer Science, or related discipline; or requisite combination of education, training, and experience.
- 10 plus years of experience in a clinical trial, healthcare, or life science setting
- Experience hosting audits, preferred
- Experience in a Direct-to-Patient (DtP) model, preferred
- Requisite combination of education, training, and experience
Top Skills
What We Do
Lightship is your complete solution for decentralized clinical trials. We built our virtual-first clinical trial model from the ground up, allowing patients to participate in clinical trials from the comfort of home. Come join the team perfecting the way clinical trials are done!
Why Work With Us
The Lightship Crew makes all of what we do possible. Every person who works at Lightship serves as an invaluable part of what makes the company work, and therefore we seek to hire and retain the most capable talent in the market. Those that end up joining Lightship all share a belief in both our Guiding Principles and Core Values.
Gallery
