Project Manager

Lantere Dx and Flagship Biosciences have recently merged to provide the most advanced tissue image analysis, clinical support, and diagnostics services that help pharmaceutical companies develop the solutions to treat, manage, and cure the world’s most challenging medical conditions.  It's services are designed to reduce risk, streamline development and improve clinical/regulatory success.  None of this can be done without a strong, talented team of people dedicated to moving medicines forward.  We are currently seeking an experienced Project Manager to join our talented team. 

Job Summary

The Project Manager is responsible for planning, initiating, overseeing, and closing clinical and nonclinical research projects to ensure they are delivered on time, within scope and budget, and aligned with client expectations. Serving as the key liaison between internal scientific and operational teams and external clients, the Project Manager plans and helps designate project resources, tracks budgets, monitors progress, and ensures key stakeholders are regularly informed throughout the project lifecycle. This position requires an individual who is extremely organized, has keen attention to detail, and has the flexibility to work across departments in a regulated laboratory environment.

Key Responsibilities

Project Management

• Plan, initiate, and manage clinical and nonclinical research projects from initiation through closure per the Statement of Work (SOW) and within the contracted budget.
• Assist in defining project scope and objectives with all relevant stakeholders, ensuring technical feasibility, and confirm all necessary study information is obtained from the client and the SOW/quote.
• Set up and maintain projects within project management software; develop and maintain timelines, milestones, and deliverables, adjusting as changes occur.
• Monitor project progress, proactively address risks or delays, and escalate issues to functional management when needed.
• Coordinate cross-functional teams including histology, image analysis, science, pathology, quality assurance, business development, and ensure resource availability and allocation.
• Manage study planning and set-up activities, including when needed coordination of third parties/vendors.
• Develop project-specific tools for tracking work and/or samples as needed.
• Complete project retrospectives with teams to capture lessons learned and implement process improvements that standardize and streamline project management systems.

Client Communication

• Serve as the primary point of contact and client advocate throughout the project lifecycle, developing long-term client relationships.
• Organize and lead client kickoff meetings, data presentations, milestone meetings, and project close-out meetings.
• Participate in and document client calls and project status meetings; provide regular updates, timelines, and deliverable tracking to clients and internal team members.
• Coordinate client requests (e.g., turnaround times, additional work) and shipping and receiving logistics.
• Resolve client complaints by investigating problems, developing solutions, and making recommendations to management; solicit client feedback through satisfaction surveys.

Study Operations and Coordination

• Coordinate sample receipt and check-in following applicable SOPs; confirm correct shipments and reconcile discrepancies with the client.
• Adaptively schedule incoming and ongoing studies, ensuring realistic turnaround times and deadlines.
• Support reporting activities, including report and protocol writing/review and data transfers.
• Manage project archives, including all required logs, charts, and files, and coordinate the return of materials upon project completion.

Financial and Business Development

• Track project budgets, meet budgetary objectives, and adjust project constraints based on financial analysis.
• Track and initiate invoicing of project deliverables at appropriate times (project stages and/or dates).
• Report project progress and revenue forecasts to internal stakeholders and senior management on regular basis.
• Collaborate with Business Development to onboard and integrate new clients.

Quality and Compliance

• Complete all job responsibilities in accordance with Lanterne Dx SOPs, company policies, and applicable regulatory requirements (CAP, CLIA, GLP).
• Collect and maintain all required study documentation (study design, protocols, sample IDs, quotes/SOWs), including binders for CLIA-designated studies.
• Assist in quality management activities, including audits, non-conformances, and CAPAs; create, review, and update SOPs.
• Complete all role-required training and document review in accordance with SOPs.
• Participate in the Safety Committee to support proper safety monitoring.

Other Responsibilities

• Maintain professional and technical knowledge by attending workshops/webinars and participating in continuing education.
• Continually seek more efficient ways to improve workflow, lab capacity, communication, and customer satisfaction.
• Travel to client sites, partners, and scientific meetings as needed (up to 10%).
• Other duties as assigned.

Qualifications

Minimum Requirements

• BA/BS in a life science (e.g., Molecular Biology, Biochemistry, Pharmacology) or science related field; AA/AS considered with additional experience.
• 3- 5 years relevant project coordination or project management experience in a Life Science or CRO setting .
• Proficient in Microsoft Office applications and project management software.
• Extremely organized, with keen attention to detail, especially in written work.
• Excellent verbal and written communication skills; fluent in English.
• Ability to effectively prioritize and manage multiple projects simultaneously.
• Flexibility to work across departments and build thorough knowledge of company processes.

Preferred Qualifications

• PMP Certification.
• Experience in a CAP/CLIA- and/or GLP-regulated laboratory, CRO, or diagnostics services environment.
• Working knowledge of histology, immunohistochemistry (IHC), fluorescence in situ hybridization (FISH), digital pathology/image analysis, or similar technologies.