Lightship

Director

• Establishing the comprehensive quality management system for clinical trials
• Participating in establishing various operational processes for clinical trials
• Leading efforts to author and revise Standard Operating Procedures (SOPs)
• Proactively reviewing policies and providing input on compliance matters
• Leading Quality Management Reviews (QMRs)
• Establishing key performance indicators (KPIs) for clinical trials
• Providing business process ownership for computerized systems
• Providing advice on compliance matters
• Overseeing controlled documents across Lightship
• Leading clinical trial risk management activities
• Establishing quality oversight mechanisms for ongoing trials
• Leading vendor audits on behalf of the company
• Hosting and/or participating in client audits and regulatory inspections
• Identifying areas for continuous improvement
• Providing training in Good Clinical Practice (GCP) topics
• Managing direct reports
• Other duties as assigned

Director, Quality

Accountant

• Preparing and booking general ledger entries to ensure a timely and accurate monthly close
• Preparing monthly account reconciliations of general ledger balance sheet accounts, department spend review, identifying/resolving discrepancies and reporting financial misstatements
• Assisting with Accounts Payable/Receivable or other projects and tasks as needed
• Answering accounting and financial questions by researching and interpreting data
• Assisting with preparing consolidated financial statements

Clinical Operations

• 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
• Ensuring project management systems are updated weekly to reflect accurate project status
• Serving as a point of escalation for project team members
• Participating in revenue forecasting and review of project actual unit/hours efficiency against budget
• Organizing and leading study team meetings, and meetings with sponsors / vendors / partners as applicable

Clinical Project Manager

People Operations

• Build a scalable, data-driven, end-to-end recruitment process across all levels of the company
• Ensure recruitment collateral is values-aligned and represents the Lightship brand
• Implement non-biased talent acquisition strategies to build a diverse and inclusive team
• Support recruiting workflow: create & post jobs, sourcing, scheduling interviews, share offer details, initiate pre-employment screening, facilitate onboarding and orientation
• Support DEIB best practices in outreach and interview process
• Build, implement, and iterate a values-aligned performance management process and feedback mechanisms
• Assess and improve performance management programs, job descriptions, performance standards, and evaluation tools
• Transition HR systems including PEO, ATS, and other systems to scale with growth
• Build and evolve HR policies, procedures, employee handbook, and internal processes
• Act as employee champion and change agent for onboarding, offboarding, and employee relations
• Support annual engagement surveys, internal reporting, HRIS and personnel records management, and exit interviews
• Provide leadership on people-related issues and guide managers/employees in resolving employee relations issues through conflict resolution and coaching
• Identify, implement, and maintain People-focused technology platforms (ATS, HRIS, Employee Engagement Software, etc.)
• Oversee accuracy and maintenance of payroll data, process payroll and off-cycle payments for multiple global entities, maintain tax filings, and manage garnishment orders
• Maintain Lightship’s total rewards philosophy: compensation, bonus, and equity philosophies

Director, Quality

Accountant

Clinical Project Manager

Fractional Director, People