Overview 

Lightship is the premier provider of enterprise level, direct-to-patient (DtP) clinical research solutions. We engage patients at home, making participation in clinical research more accessible for everyone.  

Lightship is seeking an experienced leader to direct clinical operations activities for the clinical research studies conducted by Lightship. This includes managing all aspects of clinical operations, including protocol and consent form development; vendor selection and management; developing and managing budgets, timelines, and contracts; overseeing study set-up, conduct, and close out; and completing appropriate reporting as needed. The Director of Clinical Operations will also implement departmental strategies, drive program metrics, analyze project risks and mitigation plans, and develop solutions to complex, multi-faceted problems. This role includes a focus on quality, ensuring that clinical studies are conducted according to company SOPs and all GCP, ICH, and FDA requirements.  

This position is remote, and a successful candidate will possess a willingness and desire to work independently without significant supervision. Additionally, this position will require moderate travel.

You will be responsible for: 

Study Conduct: 

  • Overseeing and managing all clinical aspects of studies; ensuring that assigned studies adhere to approved protocols 
  • Establishing key performance metrics to monitor progress of studies 
  • Interacting with sponsors, clients, and partners in governance relationships and problem resolution 
  • Contributing to the assessments of studies for operational feasibility in the DtP model  
  • Participating in the selection and management of external vendors, including developing vendor specifications and reviewing vendor reports, budgets, and invoices 
  • Preparing / reviewing site-specific study materials (e.g. informed consent, operational guidelines, training manuals) 
  • Participating in the development and management of study budgets; reviewing and approving clinical invoices against approved budgets 
  • Providing study-specific training to clinical research personnel, as applicable 
  • Developing, implementing, and standardizing departmental workflows and processes   
  • Forecasting resource needs, ensuring studies are appropriately staffed, and identifying the point where additional hiring is required 
  • Establishing and maintaining effective communication and collaboration with Lightship personnel from various functional areas, including quality and regulatory affairs, technologylegal, designrecruitment, finance, etc.  

Personnel Management: 

  • Participating in the hiring process and evaluation of study personnel, including developing performance goals and objectives 
  • Providing guidance and leadership to junior team members to increase competencies and development growth 
  • Helping to establish training program for study personnel 

Compliance:  

  • Maintaining current working knowledge of the applicable regulations concerning development and conduct of clinical studies that involves human research patients (e.g. CFRs, ICH) 
  • Contributing to the development, implementation, and maintenance of clinical processes, SOPs, and systems across Lightship 
  • Supporting audits and inspections, as required 

Additional Responsibilities: 

  • Other related duties as assigned 

We are excited to speak with someone who has: 

Required knowledge, skills, and abilities 

  • Knowledge of the healthcare system and patient visit flow 
  • Experience in setting up and managing logistics vendors for conducting clinical research 
  • Ability to work in a dynamic, fast-paced environment 
  • Ability to critically review protocols and provide comprehensive analysis of components required to conduct research studies 
  • Strong interpersonal skills 

Education and experience 

  • 10+ years of experience in clinical trials conduct, clinical care, and / or medical care 
  • Management experience 
  • Ability to establish and tactically execute strategic vision for a department  
  • Ability to establish and maintain strong professional relationships 
  • Strong written and verbal communication abilities 
  • Attention to detail 
  • Bachelor of Science Degree, required; graduate degree in healthcare preferred; or requisite combination of education, training, and experience 

We would like to offer you a generous benefits package including: 

  • Health, dental & vision that are effective on day one of employment 
  • 401K with company match 
  • Twelve-week maternity leave with 100% of salary 
  • Six-week parental leave with 100% of salary 
  • Short & long-term disability 
  • Generous Paid Time Off (PTO), plus holidays and bereavement leave 
  • Life insurance 
  • Pre-tax commuter benefits 
  • Fitness reimbursement 
  • Employee assistance program 
  • Employee discounts (retail, hotels, food, restaurants, car rentals, and much 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, or sexual orientation or any other status protected by applicable law.

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