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 to clinical studies. Our end-to-end hybrid delivery model, our diversity of skillsets, and inhouse 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.

Lightship is seeking an individual with experience in regulatory and compliance processes associated with executing clinical trials to join our team as Director of Compliance, reporting to the VP of Quality & Compliance. The candidate should be process-minded and possess a strong background in and history of successfully building and maintaining efficient quality systems. This individual will work in a pivotal role collaborating across the organization, with sponsors and interfacing with regulators to ensure successful study execution and acceptance of Lightship’s clinical studies.

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.

Director of Compliance is responsible for:

  • Maintaining the quality management system at Lightship
  • Participating in maintaining and improving various operational processes for quality, clinical operations, and technology development, including deviations / CAPAs, study conduct, software development, etc.
  • Acting as the process owner for deviations, CAPAs, audits, and QMR across Lightship
  • Reviewing policies, Standard Operating Procedures (SOPs), training documents, etc. and providing input related to sound business processes and compliance matters
  • Managing the GCP vendor qualification and approval process including conducting vendor audits on behalf of the company
  • Conducting routine Quality Management Review (QMR) meetings
  • Participating in the implementation of computerized systems as part of Lightship’s overall quality management system
  • Providing consultation to other functional areas on matters related to compliance
  • Maintain yearly internal audit schedule and conduct internal audits accordingly
  • Providing feedback and assistance in resolving compliance issues
  • Participating in client audits and regulatory inspections as a host, subject matter expert, and / or running the “war room” as required
  • Prepare for and participate in meetings with regulatory authorities, with sponsors and independently
  • Identifying areas for continuous improvement; defining improvement processes and implementing them
  • Researching compliance and regulatory topics, synthesizing the research, and developing relevant materials addressing and / or using the research
  • Other duties as assigned

Required knowledge, skills, and abilities

  • Broad knowledge and understanding of clinical trial conduct and compliance
  • Good understanding of GCP
  • Good understanding of quality management practices in a clinical research setting
  • Good problem-solving skills
  • Sound judgment with a practical understanding of compliance tactics
  • 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

  • 10 or more years of experience in a clinical research, healthcare, or life science setting
  • Experience hosting audits and inspections
  • Certified auditor, preferred
  • Experience in a Direct-to-Patient (DtP) model, preferred
  • Bachelor’s Degree in Science, Engineering, or related field; or requisite combination of education, training, and experience, required

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 private supplemental healthcare (medical, dental, and vision) for you and your family, effective on day one of employment.  
  • Holidays Policy (25 days), plus public bank holidays and bereavement to help support work life balance.
  • Company sponsored group pension program w/ company contribution.
  • Generous paid parental leave
  • Group Life Cover

Our commitment to diversity & inclusion:

Lightship promotes a diverse and inclusive workplace. Lightship considers all applicants without regard to racial or ethnic origin, religious or philosophical beliefs, health, sexual orientation, or any other status protected by applicable 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, may require vaccination against COVID-19.

#jobs #careers #nowhiring #hiringnow 

 

Apply for this Job

* Required