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. To be successful at Lightship, you need to be passionate about our mission of redefining trials and providing hope for all, and our core values: we believe in people, we embrace change, we serve others, and we make an impact.
Clinical Study Manager is an experienced clinical research professional who possesses a strong background in a scientific field and is knowledgeable about clinical research from perspectives of patients, sponsors, investigators, and coordinators. In addition, this individual is well-versed in effective use and implementation of clinical research methodologies, enabling technologies, and platforms.
Clinical Study Manager is responsible for all aspects of planning, start-up, implementation, and closeout of Lightship’s new and ongoing clinical studies in multiple therapeutic areas. This includes but not limited to training, directing, and managing Lightship clinical research coordinators, mobile nurses, and all other study personnel. Clinical Study Manager must be able to collaborate effectively with internal and external stakeholders, communicating project status, escalating issues, and troubleshooting routine inquiries.
This individual possesses expert level written and verbal communication skills, strong decision-making abilities, clinical project management skills and attention to detail. The As a representative of Lightship to clients and partners this individual must also have possess effective interpersonal skills.
Given Lightship’s distributed model and the remote nature of this position 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 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
Clinical Study Manager is responsible for:
- Overseeing clinical research conduct, including study start-up, enrollment, execution, and close-out
- Leading the multifunctional study management team responsible for flawless execution of Lightship clinical studies
- Overseeing all operational aspects of assigned clinical studies, including but not limited to:
- Managing, reviewing, and maintaining study related and essential documents (e.g. financial disclosure forms, study manuals, etc.)
- Ensuring and supporting regulatory and ethical compliance for assigned studies
- 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 technological solutions are designed and configured per specifications of 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
- Projecting and overseeing resource utilization and clinical study finances
- Developing, tracking, and reporting study specific KPIs for each study
- 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 needed 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
- Support and participate in business development activities when required
Clinical Study Manager 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 presentation 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; or requisite combination of education, training, and experience
- Previous remote experience, required
- Experience working at a CRO or sponsor, preferred
- 5 years of related clinical research management experience, preferred
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, do require vaccination against COVID-19.
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