Overview 

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

Lightship is seeking an experienced clinical research professional to join our team as a Study Manager. The candidate should possess a strong background in a scientific field and be knowledgeable about clinical research from perspectives of patients, sponsors, investigators, coordinators, patient recruiters, study monitors, and clinical research organizations. In addition, he or she should be well-versed in clinical research technologies and systems and be able to implement and use them effectively 

Study Manager will be responsible for implementing and conducting Lightship’s new and ongoing clinical studies in multiple therapeutic areas; for training, directing, and managing clinical research coordinators, nurses, and other study personnel; and for collaborating effectively with study sponsors / vendors / partners and various Lightship business units to deliver high quality clinical research results.  

This position is remote, and a successful candidate will possess a willingness and desire to work independently without significant oversight. Additionally, this position will require travel – approximately 25%. 

You will be responsible for: 

  • Overseeing clinical research conduct, including study start-up, enrollment, execution, and close-out 
  • Overseeing all operational aspects of assigned clinical studies, including but not limited to: 
  • Preparing, reviewing, and maintaining study related and essential documents (e.g. Form FDA 1572, financial disclosure forms, study manuals, etc.) 
  • Coordinating IRB correspondence and communication, ensuring that all approvals are obtained as required 
  • Managing study supplies and equipment 
  • Organizing / ensuring that appropriate study trainings are delivered 
  • Ensuring that the necessary electronic systems are configured as needed for each study 
  • Ensuring that the vendors / personnel needed for each study are prepared, available, and trained 
  • Working with internal and external study monitors to address issues and provide resolutions 
  • Acting as the main point of contact for study investigator, study personnel, and sponsors / vendors / partners to ensure smooth communication and collaboration  
  • Developing a project plan and defining operational guidelines for each study; managing each study per project plan, including timelines and budget 
  • Organizing and managing internal team meetings, study-specific meetings, and meetings with sponsors / vendors / partners as applicable 
  • Attending cross-functional meetings as need to represent a specific study or Clinical Operations functional area 
  • Proactively identifying potential study issues and / or risks, providing recommendations, and implementing solutions 
  • Participating in the development, review, and implementation of standard operating procedures and processes 
  • Preparing and delivering study-related information to study teams and sponsors / vendors / partners, including but not limited to: 
  • Recruitment, screening, and enrollment reports 
  • Expectations and updates regarding timelines 
  • Summary of issues and their resolutions 
  • Summary reports of data flow, protocol deviations, safety reports, and other reports as applicable 
  • Participating in the selection, training, and evaluation of personnel to ensure efficient operation of the functional area, with updates / metrics to management as requested 
  • Participating in mentorship and career development of the assigned personnel 

We are excited to speak with someone who has: 

Required knowledge, skills, and abilities 

  • Extensive clinical research knowledge and cross-functional understanding of clinical research methodology 
  • Highly developed leadership skills to successfully lead a clinical study team  
  • Ability to successfully and independently manage conflicting priorities and time demands  
  • Ability to successfully manage conflicting / incomplete / unexpected information and situations 
  • Ability to work collaboratively with multiple individuals and groups 
  • Ability to adjust workload based on changing priorities  
  • Strong analytical and problem-solving skills  
  • Strong attention to detail 
  • Outstanding organizational skills with the ability to multi-task and prioritize  
  • Excellent interpersonal, verbal, written, and presentational skills  
  • Comfortable in a fast-paced start-up environment 

Education and experience 

  • Bachelor’s Degree in nursing, science, or healthcare-related field, required; advanced degree in a scientific field, preferred 
  • Previous remote experience, required 
  • 5 years of related clinical research management experience, preferred 

We would like to offer you:  

  • A platform to develop your clinical research management skills 
  • An opportunity to help re-envision how clinical research is executed and deliver high-quality research outputs 
  • The chance to work with a patient-centered, clinically oriented, collaborative team to deliver enterprise grade direct-to-patient clinical research solutions at scale 
  • An unmatched opportunity to grow as part of an early stage startup 
  • Competitive compensation including a performance bonus 

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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