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

Responsibilities

• 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 venders 
• Develops key study documents, including but not limited to, Project Management Plans, Monitoring Plans (in collaboration with the Clinical Lead [CL]), 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. 
• 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 (e.g., financial, and confidential) 
• Ensures study conduct in accordance with appropriate SOPs, ICH/GCP Guidelines and local regulations 
• Support and work closely with the Business Development (BD) team 
• Participate in customer audits and regulatory inspections 
• Assist with vendor management on assigned project(s) 
• Collaborate with Quality Assurance when CAPA or deviations are necessary to be documented/initiated 
• Manage project budget and scope (including scope changes) 
• Review and approve project level, site level, customer invoicing, and vendor expenses, as needed 
• Identify, quantify, and communicate changes in scope (internally and externally) 
• Manage changes to the project scope (Change Notification process) 
• Lead Internal, External, and study-related meetings, as applicable 
• Develop study risk management and planning 
• Manage revenue activities (tracking budgets, forecasting hours, etc.) with little support needed

Requirements

• For Project Manager level: A minimum of 5+ years of experience in clinical research or equivalent in education and experience. Relevant experience as a CRA preferred.
• For Senior Project Manager Level: A minimum of 7+ years of experience in clinical research or equivalent in education and experience. At least 3 years project management experience overseeing multiple full-service projects simultaneously preferably in a CRO environment.

• 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, strongly 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 be detail oriented.
• Advanced skills in computer operation, spreadsheet creation/maintenance, and word processing are essential.
• Proficiency in some software system(s) as appropriate for needs of department required. 
• Have an understanding of financial terminology and project financial management.
• Have an understanding of contractual management.

Position requires: ordinary ambulatory skills and physical coordination sufficient to move about conference or meeting locations as required; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time.

Disclaimer:

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. Lexitas Pharma Services, Inc., at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. Lexitas Pharma Services, Inc., at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.