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.
Our Director, Clinical Operations will be an experienced leader who directs and oversees all clinical operations activities for the clinical research studies conducted by Lightship.
This includes managing protocol and consent form development; vendor selection and management; developing and managing study, project, and departmental budgets; establishing timelines and milestones; review and execution of contracts; overseeing study set-up, conduct, and close out; and completing appropriate reporting as needed.
The Director, Clinical Operations also implements departmental strategies, drives program metrics, establishes and reviews KPIs, analyzes project risks and mitigation plans, and develops 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 travel – approximately 25%.
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!
Director of Clinical Operations is responsible for:
- 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, technology, legal, design, recruitment, finance, etc.
- 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
- 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
- Other related duties as assigned
Director of Clinical Operations 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
- Ability to mentor, coach, and manage colleagues
- 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
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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