Lightship is the premier provider of enterprise level, technology enabled decentralized clinical research services. In this capacity, Lightship makes research participation more accessible for everyone by functioning as a telemedicine-enabled clinical research site within a research study.
Lightship is seeking a Clinical Quality Manager with experience in managing and / or monitoring the start-up, execution, and close-out of clinical trials.
The Clinical Quality Manager provides overall support for the clinical team from a Quality perspective and performs comprehensive clinical study risk assessments and risk-based internal audits of ongoing clinical trials at Lightship. The Clinical Quality Clinical Quality Manager will work cross functionally with the clinical and technology teams to ensure trials are executed to ensure patient safety, data integrity, and protocol compliance.
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. This is a temporary employee position, initially for a period of 6 months, with strong potential for extension beyond that timeframe. As a full-time temporary with Lightship, you are also eligible for benefits during the duration of the temporary assignment.
Clinical Quality Manager is responsible for:
- Leading clinical study risk assessments
- Creating and implement risk-based clinical study internal audit plans
- Participating in establishing various operational processes for clinical trials, including informed consent, investigator oversight, documentation, etc.
- Reviewing policies, Standard Operating Procedures (SOPs), training documents, etc. and providing input related to sound business processes and compliance matters
- In collaboration with Clinical Operations personnel, establishing key performance indicators (KPIs) for Lightship’s trials
- Providing consultation to other departments on matters related to compliance for ongoing trials; participating in trial team meetings as requested
- Establishing efficient quality oversight mechanisms for ongoing trials; providing feedback and assistance in resolving operational problems
- Participating in client audits and regulatory inspections as a subject matter expert, host, and / or running the “war room” as required
- Identifying areas for continuous improvement, defining improvement processes, and implementing them
- Other duties as assigned
The Clinical Quality Manager 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
- Ability to collaborate effectively with various groups within the company
Education and experience
- Bachelor’s degree in Science, Engineering, or related field, or requisite combination of education, training, and experience
- 5+ years of experience in a clinical trial, healthcare, or life science setting
- Experience in a Direct-to-Patient (DtP) model, preferred
We would like to offer you:
- An opportunity to help re-envision how clinical research is executed with inclusivity, increased diversity and accessible at the core
- The chance to work with a patient-centered, clinically-oriented, collaborative team to support in the delivery of enterprise grade direct-to-patient clinical research solutions at scale
- An unmatched opportunity to grow as part of an early stage startup with industry veterans, high-caliber investors, and a massive market opportunity
- Competitive compensation
Generous benefits package, including:
- Top notch healthcare (medical, dental, and vision) for you and your family.
- Unlimited Paid Time Off (PTO), plus paid holidays and bereavement to help support work life balance.
- A 100% 401(k) company match for up to 4% of eligible contributions with an immediate vesting.
- Generous paid parental leave
- Short & long-term disability
- Life insurance and More!
Our commitment to diversity & inclusion:
Lightship is an equal opportunity employer and promotes a diverse and inclusive workplace. Lightship considers all applicants without regard to race, color, religion, creed, national origin, age, sex, marital status, ancestry, disability, veteran status, gender identity, genetic information, sexual orientation, or any other status protected by applicable law. EEO is the Law
Please note: For the safety of our patients and each other, all positions at Lightship that require travel, in-person participation, or are patient-facing, do require vaccination against COVID-19.
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