Clinical Project Manager

Overview

Lightship is the virtual-first provider that is perfecting the way clinical trials get done. Because clinical research plays such a vital role in bringing life-enhancing and lifesaving innovations to market, Lightship pursues operational excellence to clinical studies. Our end-to-end hybrid delivery model, our diversity of skillsets, and inhouse care team ensure sponsor success and the best possible patient experience. With a problem-solving mindset, we strive to make every clinical trial better than the last. Operational excellence is not a goal, but a way of doing things at Lightship.

The Clinical Project Manager possesses a strong background in a scientific field and is knowledgeable about clinical research from perspectives of patients, sponsors, investigators, and research coordinators. In addition, this individual is well-versed in effective use and implementation of clinical research methodologies, enabling technologies, and platforms.

The Clinical Project Manager is responsible for implementing and conducting Lightship's new and ongoing clinical studies in multiple therapeutic areas; owning and achieving interim and final contractual deliverables throughout the entire project lifecycle according to time, quality/scope, and cost constraints; while also managing cross-functional teams and client expectations to achieve client satisfaction, including, collaborating effectively with internal and external stakeholders, communicating project status, escalating issues, and troubleshooting.

Given Lightship's distributed model and the remote nature of this position, candidates will possess a willingness and ability to work independently without significant oversight. Additionally, this position requires moderate travel (approximately 30%).

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 virtual-first clinical research solutions at scale
• An unmatched opportunity to grow as part of an established 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.
• A home office stipend to set yourself up for success in our distributed working environment
• Company provided laptop, your choice of a PC or a Mac
• Monthly stipend for internet and phone expenses
• Generous paid parental leave
• Short & long-term disability
• Life insurance and More!

Clinical Project Manager is responsible for:

• Leading cross-functional teams and third parties/vendors to ensure successful project delivery. Overseeing clinical research conduct, including study start-up, enrollment, execution, and close-out
• Acting as liaison with the client and managing client contractual, organizational and relationship needs/expectations, related to operational delivery of assigned projects

• Managing project contractual deliverables and modifications, and preparing and delivering study-related updates, dashboards and reports to study teams, senior management, and sponsors / vendors / partners, including but not limited to:

• Recruitment, screening, and enrollment reports
• Key Performance Indicators / Metrics
• Status of Deliverables
• Summary of risks / issues and their mitigation / resolutions

• Summary reports of data flow, protocol deviations, safety reports, and other reports as applicable

• Ensuring project management systems are updated weekly to reflect accurate project status
• Serving as a point of escalation for project team members
• Ensuring project resources are appropriately assigned in project management system and updating forecasted project hours per resource to accurately reflect project needs. Reviewing and approving reported project hours and ensuring project team report hours appropriately and in a timely fashion.
• Participating in revenue forecasting and review of project actual unit/hours efficiency against budget.

• Identifying and managing scope changes with the client with support of the project Director
• Ensuring Director and Client Partner are kept informed of project progress through the provision of appropriate and regular updates
• Developing operational plans (including operations guidelines, manuals and project plans as needed)
• Overseeing all operational aspects of assigned clinical studies in accordance with local regulations, ICH GCP guidelines, SOPs (Standard Operating Procedures), and project specific plans, including but not limited to:

• Managing, reviewing, and maintaining study-related essential documents (e.g., financial disclosure forms, study manuals, etc.)

• Coordinating IRB/IEC correspondence and communication, ensuring that all approvals are obtained as required
• Overseeing that study supplies and equipment are procured and delivered to patients and/or sites.
• Organizing / ensuring that appropriate study training is delivered, and maintaining the project specific training matrix and ensuring project team compliance with project specific training
• Ensuring that the necessary technological solutions are designed and configured per study specifications
• Ensuring that the vendors / personnel needed for each study are prepared, available, and trained, and managing assigned vendors as necessary

• Working with 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
• Working with Legal to support coordination of contracts with sites and vendors
• Working with Finance to ensure accurate and timely invoicing to sponsors and tracking and payment of invoices from investigators and vendors
• Preparing requisite project status updates in keeping with project plans at a set cadence, and tailoring messaging as necessary for different internal and external audiences

• Organizing and leading study team meetings, and meetings with sponsors / vendors / partners as applicable
• Participating in the development, review, and implementation of standard operating procedures, manuals, tools, and training materials
• Identifying, documenting and sharing lessons learned and best practice throughout each project

• Supporting audits and inspections, as required
• Ensuring adherence to company SOPs, policies, and guidelines at the project-level

Clinical Project Manager has:

• Required knowledge, skills, and abilities

• • Excellent working knowledge, skills, and abilities in clinical research project management.
  • Highly developed spoken and written communication skills; excellent presentation skills
  • Knowledge/expertise in the applicable regulations/guidelines for, and the conduct of, virtual clinical trials preferred
  • Strong interpersonal, collaboration and time management skills.

• • Strong leadership skills and ability to coach and mentor project team.
  • Ability to establish and maintain effective working relationships with project team members, other cross functional stakeholders and clients.
  • Ability to function in a global role managing cross-functional service areas.
  • Proactive, innovative problem solver with good analytical and critical thinking skills to appropriately identify the root cause of issues and implement solutions, escalating to management for support appropriately.
  • Influences stakeholders at all levels with confidence and can adapt style to deliver messaging. Issues may be complex, audience perspectives may be divergent, and information may be non-routine in nature.

• • Able to work in a fast-paced, evolving environment.
  • Ability to embrace and manage change, be agile and adaptable.
  • Able to work independently in an unstructured environment

• Education and experience
  • Undergraduate, health-related degree OR an equivalent combination of education, training and experience sufficient to successfully perform the key responsibilities of the job

• • 4-6 years of relevant clinical research experience and solid knowledge and understanding of clinical project management
  • Project Management Training or Certification, preferred

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

Lightship is an E-Verify employer. Find out more here: Right to Work Poster E-Verify Participation Poster

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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