Project Manager

We’re looking for purpose-driven, passionate individuals to join our team. From clinical to commercial to supporting functions, Lexitans believe in the common mission: to be the best ophthalmic product development organization to partner with. 

Overview

Provides operational support to Project Directors (PD). Responsible for the day-to-day management of project activities and deliverables. Serves as a liaison with the sponsor and vendors across all functional areas of the project.  Assists in managing the project and ensuring that the quality of interactions and communications across the project are consistent with the sponsor and company expectations.

Responsibilities

• Leads the cross functional project team.
• Serves as the primary counterpart and point of escalation for the sponsor.
• Manages project timelines and deliverables (e.g., Statistical Analysis Plan, Data Management Plan, Project Management Plan, Clinical Monitoring Plan, Clinical Study Report, and all project documents)
• Manages project budget and scope (including scope changes)
• Reviews and approves project level, site level, customer, and vendor invoices.
• Identifies, quantifies, and communicates changes in scope (internally and externally)
• Manages changes to the project scope (Change Notification process)
• Leads Internal, External, and study-related meetings, as applicable.
• Trains project team on project scope and budgeted hours and time entry guidelines
• Reviews or oversees review of monitoring trip reports, if applicable.
• Manages vendors, including the implementation and coordination of vendor’s Scope of Work (SOW), if applicable
• Develops study risk management and planning.
• Initiates functional lead resourcing requests for the project.
• Leads the set up and management of project vendors.
• Performs project level vendor management activities (budget and scope management)
• Reviews and finalizes Project Management Plan, Risk Management Plan, and other key study documents.
• Collaborates with Quality Assurance when CAPA or deviations are necessary to be documented/initiated.
• Drafts project Related CAPAs (formulation of response to QA)
• Reviews and finalizes project status and progress reports internally and externally.
• Provides performance feedback on project team members.
• Reviews and finalizes forecasting and revenue activities – (tracking budgets, forecasted hours/visits, invoicing)
• Supports business development (Handover Meeting, BD Activities, Bid Defense)
• Oversees project system set-up/development.
• Ensures coordination and execution of study training compliance.
• Oversees TMF progress and address issues.
• Participates in customer audits and regulatory inspections.

Requirements

Education:

B.S./B.A. or advanced degree in a health-related or scientific field preferred.

Experience:

• A minimum of 5+ years of experience in clinical research or equivalent in education and experience.
• At least 6 months of project management and study team oversight experience preferably in a CRO environment.

Skills:

• Study planning and set-up, maintenance, and close-out experience
• Must have a solid understanding of clinical research operations including GCP, regulatory requirements, and operational procedures.
• Ophthalmology experience, preferred. 
• CRO experience preferred.
• Highly customer service oriented and have creative initiative with a positive attitude.
• Have an understanding and share the organizational values of developing and maintaining good relationships internally and externally. Quality of interactions reflects emphasis on relationships.
• Possess the ability to work in a fast-paced environment and easily adapt to changing priorities.
• Excellent team management and communication skills (written and verbal), strong problem-solving skills, and detail oriented.