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.

Apply for this Job

* Required
  
  


U.S. Equal Opportunity Employment Information (Completion is voluntary)

Individuals seeking employment at Lightship are considered without regards to race, color, religion, national origin, age, sex, marital status, ancestry, physical or mental disability, veteran status, gender identity, or sexual orientation. You are being given the opportunity to provide the following information in order to help us comply with federal and state Equal Employment Opportunity/Affirmative Action record keeping, reporting, and other legal requirements.

Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file.

Race & Ethnicity Definitions

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.


Form CC-305

OMB Control Number 1250-0005

Expires 05/31/2023

Voluntary Self-Identification of Disability

Why are you being asked to complete this form?

We are a federal contractor or subcontractor required by law to provide equal employment opportunity to qualified people with disabilities. We are also required to measure our progress toward having at least 7% of our workforce be individuals with disabilities. To do this, we must ask applicants and employees if they have a disability or have ever had a disability. Because a person may become disabled at any time, we ask all of our employees to update their information at least every five years.

Identifying yourself as an individual with a disability is voluntary, and we hope that you will choose to do so. Your answer will be maintained confidentially and not be seen by selecting officials or anyone else involved in making personnel decisions. Completing the form will not negatively impact you in any way, regardless of whether you have self-identified in the past. For more information about this form or the equal employment obligations of federal contractors under Section 503 of the Rehabilitation Act, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

How do you know if you have a disability?

You are considered to have a disability if you have a physical or mental impairment or medical condition that substantially limits a major life activity, or if you have a history or record of such an impairment or medical condition.

Disabilities include, but are not limited to:

  • Autism
  • Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, or HIV/AIDS
  • Blind or low vision
  • Cancer
  • Cardiovascular or heart disease
  • Celiac disease
  • Cerebral palsy
  • Deaf or hard of hearing
  • Depression or anxiety
  • Diabetes
  • Epilepsy
  • Gastrointestinal disorders, for example, Crohn's Disease, or irritable bowel syndrome
  • Intellectual disability
  • Missing limbs or partially missing limbs
  • Nervous system condition for example, migraine headaches, Parkinson’s disease, or Multiple sclerosis (MS)
  • Psychiatric condition, for example, bipolar disorder, schizophrenia, PTSD, or major depression

1Section 503 of the Rehabilitation Act of 1973, as amended. For more information about this form or the equal employment obligations of Federal contractors, visit the U.S. Department of Labor's Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.