For legal, insurance, and corporate leaders responsible for vital outcomes, Lexitas delivers highly responsive professional services paired with powerful technology to help move your practice, and your business, forward. 

Accuracy, timeliness, and reliability are the cornerstones of Lexitas service, which is why we are entrusted with mission imperative support functions by organizations of all sizes.

Lexitas

Project Manager

Manage clinical research projects for an ophthalmic product development organization.

• Provides operational support to Project Directors (PD).
• Responsible for 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.
• Provides guidance to CRAs, COS, and PS in the planning, implementation, and closeout of clinical research projects.
• Serves as a point of contact for issue escalation.
• Serves as a study contact for Sponsor and project vendors.
• Develops key study documents, including but not limited to, Project Management Plans, Monitoring Plans, Informed Consent Forms, Case Report Forms, Study Reference Manuals/Regulatory Binders and source document templates, as applicable for study needs.
• Reviews or oversees review of monitoring trip reports, if applicable.
• Manages vendors, including implementation and coordination of vendor’s Scope of Work, if applicable.
• Manages and provides oversight of study budget and timelines.
• Identifies, resolves, or escalates issues involving study timelines and deliverables.
• Develops, implements, and oversees enrollment plans and strategies.
• Oversees system development, ensuring suitable fit for the protocol.
• Collects, tracks, and reports established Key Performance Indicators such as query resolution, safety data collection or issues, drug reconciliation/shipment, site and patient enrollment, protocol deviations, etc.
• Identifies and establishes the suitability of study investigators and their investigative sites and liaises with them to ensure compliance with all necessary study requirements, approvals, and agreements.
• Ensures study conduct in accordance with appropriate SOPs, ICH/GCP Guidelines and local regulations.
• Supports and works closely with the Business Development team.
• Participates in customer audits and regulatory inspections.
• Assists with vendor management on assigned project(s).
• Collaborates with Quality Assurance when CAPA or deviations are necessary to be documented/initiated.
• Manages project budget and scope, including scope changes.
• Reviews and approves project level, site level, customer invoicing, and vendor expenses, as needed.
• Identifies, quantifies, and communicates changes in scope.
• Manages changes to the project scope.
• Leads Internal, External, and study-related meetings.
• Develops study risk management and planning.
• Manages revenue activities with little support needed.

Project Manager/Senior Project Manager

Business Development Rep

Develop relationships with biotech and pharma for business opportunities.

• Build and maintain relationships with clients (especially at the senior executive level).
• Manage client opportunities from prospecting, solution development, RFI/RFP process, BID defense, SOW finalization, and successful transition to Lexitas implementation & delivery teams.
• Promote Lexitas capabilities and solutions through lead generation activities (e.g., conferences, trade shows, webinars).
• Facilitate the preparedness of the Lexitas team in attending any client meetings.
• Positively interact with Lexitas operations personnel, keeping track of study status for projects with sponsors.
• Support the development of account strategies & implementation plans (Customer Playbooks).

Associate Director/Director, Business Development

Oversee project activities and ensure quality communications in ophthalmic product development.

• 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.
• Provides guidance to CRAs, COS, and PS in the planning, implementation, and closeout of clinical research projects.
• Develops key study documents, including but not limited to, Project Management Plans, Monitoring Plans, Informed Consent Forms, Case Report Forms, Study Reference Manuals/Regulatory Binders and source document templates, as applicable for study needs.
• 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.
• Manages and provides oversight of study budget and timelines.
• Identifies, resolves, or escalates issues involving study timelines and deliverables.
• Develops, implements, and oversees enrollment plans and strategies.
• Oversees system development, ensuring suitable fit for the protocol.
• Collects, tracks, and reports established Key Performance Indicators such as query resolution, safety data collection or issues, drug reconciliation/shipment, site and patient enrollment, protocol deviations, etc.
• Ensures study conduct in accordance with appropriate SOPs, ICH/GCP Guidelines and local regulations.

Develop and foster relationships with decision-makers to secure business opportunities.

• Build and maintain relationships with clients (especially at the senior executive level), and leverage these relationships to generate new business opportunities and drive revenue growth.
• Manage client opportunities from prospecting, solution development, RFI/RFP process, BID defense, SOW finalization, and successful transition to Lexitas implementation & delivery teams.
• Promote Lexitas capabilities and solutions through lead generation activities (e.g., conferences, trade shows, webinars).
• Facilitate the preparedness of the Lexitas team in attending any client meetings. For example, Bid Defense Meetings, 1:1 C-Suite engagements.
• Positively interact with Lexitas operations personnel, keeping track of study status for projects with sponsors and help coordinate change orders when notified of a change of scope by operations.
• Support the development of account strategies & implementation plans (Customer Playbooks) and expand through accounts.
• Manage, update, maintain & record all relevant activities in the client database (Salesforce.com) for the assigned territory to ensure its data is accurate and current so support forecasting efforts.
• Collect, compile, analyze & present data related to business development.

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