OverviewLightship is the virtual-first provider that is perfecting the way clinical trials get executed. Because clinical research plays such a vital role in bringing life-enhancing and lifesaving innovations to market, Lightship pursues operational excellence in clinical studies. Our end-to-end hybrid delivery model, our diversity of skillsets, and in-house patient 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 Senior Manager, Clinical Operations and Delivery is an experienced leader who is comfortable managing complex clinical operations activities for the clinical research studies conducted by Lightship and support business growth.  This individual manages the development of new services, tools and strategic partnerships aimed at enhancing the ability of the Clinical Operations and Delivery performance and strategic selling capabilities globally. This includes managing, mentoring and developing a team of Clinical Project Managers and Coordinators, overseeing, and ensuring the delivery of assigned projects on-time, within budget and to expected quality and client standards, and being the key point of escalation for clients and internal stakeholders to ensure risks are mitigated and issues are managed effectively.Given Lightship's distributed model and the remote nature of this position a successful candidate will possess a willingness and desire to work independently without significant oversight. Lightship expects each individual to anchor their availability in the standard operating hours for their geographic location, however, true to our values of inclusion and flexibility, this role, along with all others at Lightship, may be asked to flex work hours to accommodate US West Coast, US East Coast, and UK-based time zones, based on business need. In practice, this may translate to days that have a slightly earlier start or evenings that have a slightly later end. Culturally, we aim to balance the ability to operate across time zones with respect for each individual's daily life.Additionally, this position will require moderate travel, approximately 20%. The Senior Manager, Clinical Operations & Delivery is responsible for:

• Contributing to the direction, strategy, and performance standards for the assigned project teams
• Providing oversight of all project activities and responsibilities (including, but not limited managing protocol and consent form development; vendor selection and management; developing and managing study, project, and departmental budgets; establishing timelines and milestones; invoice review and project financial management, review and execution of contracts; overseeing study set-up, conduct, and close out; and completing appropriate reporting as needed) to ensure:
• Project tasks are delivered to high quality standards on-time and within the budget
• Services provided to clients are compliant with Lightship policies, procedures, SOPs, ICH GCP, client contractual expectations (including the approved protocol) and country-specific regulatory requirements
• Managing Clinical Project Management and Study Coordination staff to optimize employee performance levels, ensure retention of high performing Lightship team members and cultivate optimal team dynamic
• Ensuring appropriate employee resources are available to meet corporate / client/ project objectives while achieving optimal utilization of staff
• Accurately projects resource needs to ensure timely hiring of staff
• Adjusts resource allocation for project work as appropriate to ensure corporate targets are maintained while assuring client/ project objectives are achieved
• Escalates anticipated shortfall or excess in resources to senior management
• Supporting Lightship's continuous process improvement initiatives, including identifying and executing opportunities to optimize departmental performance and best practices at Lightship
• Assuring that project quality metrics align with company, client, and clinical operations objectives
• Providing input to proposals for project bids to ensure all projects can and will be managed within contractually agreed upon schedules and budgets
• Provides guidance/ insight on aspects of Clinical Operations and Delivery, as well as contingency planning, to accommodate project or therapeutic-specific nuances while identifying potential impacts of the same to budget
• Participates in client presentations and / or bid defense meetings, as required
• Supports the revision of scope and change orders
• Reviewing and approving project direct and pass-through expenditure per contract and/or company policy
• Proactively identifying potential project risks, barriers and issues and works to mitigate their impact through direct action or providing guidance to others, escalating to client partner and senior management appropriately
• Supports the development of new services, tools, and strategic partnerships to enhance Clinical Operations and Delivery's performance and strategic selling capabilities globally and within assigned region
• Establishing and maintaining effective communication and collaboration with Lightship personnel from various functional areas
• Supporting senior management in identifying hiring requirements based on departmental needs, and actively participating in candidate review, selection, and successful on-boarding
• Regularly reporting on data related to studies and other departmental initiatives to Senior management
• Participating in the evaluation of study personnel, including developing performance goals and objectives, and providing training, mentoring and support, as needed
• Contributing to the development, implementation, and maintenance of clinical processes, SOPs, and systems across Lightship 
• Supporting audits and inspections, as required
• Independently managing assigned departmental and cross functional initiatives
• Supporting other departments or cross-functional needs as the business requires
• Other duties as requested

The Senior Manager, Clinical Operations & Delivery has: Required knowledge, skills & abilities:

• Considerable knowledge of company people management policies and procedures, including hiring, performance management, people development, strategic thinking and influencing
• Strong global understanding of Clinical Research process in multiple countries
• Strong leadership skills including coaching, interviewing, and providing feedback and recognition
• Ability to establish and maintain strong professional relationships and strategic partnerships, building credibility quickly across a diverse range of functional teams, seniority, and geography
• Agile decision-making – using evidence and applying judgement to balance pace, rigor, and risk
• Excellent verbal and written communication skills
• Detail oriented with excellent organizational skills, in an environment with shifting priorities
• Adaptability to learn and work with new technology
• Ability to actively support Clinical leadership with planning of departmental vision and evolution
• Ability to manage multiple priorities in a dynamic, fast-paced environment
• Ability to critically review protocols, operation plans and project review materials such as metrics / KPIs and provide comprehensive analysis of components required to conduct successful research studies
• Ability to translate strategic objectives into operational plans and drive their execution
• Demonstrated skill operating in situations characterized by complexity, ambiguity, and high levels of uncertainty
• Negotiation skills and abilities and is able to influence with or without authority at all levels of the organization; adapting style to deliver messages or sell ideas or services
• Comfortable advising others on complex matters
• High level of energy, enthusiasm, and commitment
• Track record of project delivery. Areas of experience should include Clinical Research Services, People Management, and Project Management

Education and experience:

• Bachelor's degree or international equivalent, or requisite combination of education, training, and experience
• 7+ years relevant industry experience,
• Track record managing clinical research projects and personnel
• Experience leading the delivery of multiple/complex projects/assignments in a matrix environment to demanding deadlines with minimal direction/leadership
• Experience in critical path management, scenario planning, budget forecasting / management and risk identification / management
• Experience with the variability of assumptions supporting robust quality clinical research services plans and the ability to deliver to plan
• Experience employing highly effective decision-making strategies in resolving issues and conflicting options

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
• Great 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!

The base salary range for this role is between $137,368 and $185,000+, depending on education, skills, and experience. To determine our compensation, we use a market-based approach that is geographically neutral. We believe that this demonstrates our company value of 'believing in people' – valuing the outputs and performance of each team member.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. 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 LawLightship is an E-Verify employer. Find out more here: Right to Work Poster E-Verify Participation Poster#jobs #careers #nowhiring #hiringnow