Senior Project Specialist

Job not on LinkedIn

🕒 October 21

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

👻 Ghost score 10%

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Lexitas Pharma Services

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2011

🏥 Healthcare

💊 Pharmaceuticals

🤝 B2B

Healthcare • Pharmaceuticals • B2B

Lexitas Pharma Services is a specialized full‑service clinical research organization (CRO) focused exclusively on ophthalmology. With over 15 years dedicated to eye disease and therapy development and a team (ophthalmologists, optometrists, clinical operations specialists, and imaging experts) claiming more than 475 years of combined ophthalmology and clinical research experience, Lexitas provides end‑to‑end clinical development services — including monitoring, data management, regulatory and medical writing, and an integrated Reading Center — tailored to sponsors across cornea-to-retina indications. They emphasize personalized services, rigorous quality standards, and operational support for clinical trials in ophthalmic subspecialties.

📋 Description

• Provide support to Project Management and other study team members • Keep study-related essential documentation current and filed • Provide expertise in study start-up and overall study coordination • Mentor and train Project Specialists and provide support to more junior CRCs • Serve as a back-up point of contact during Project Manager or Associate Project Manager absences • Set up internal and sponsor team meeting invites, agendas, and minutes, including Kick off Meetings and Investigator Meetings • Set up and maintain CTMS project-level information • Draft project plans, including the Project Management Plan, Risk Management Plan, and eTMF Plan • Draft internal and external project status and progress reports • Oversee project team training and compliance • Draft monthly forecasting and revenue units/activities, including tracking budgets, forecasted hours/visits, and invoicing • Administer Customer Satisfaction surveys through Marketing • Set up and update project timelines with input from the Project Manager • Manage DSMB, DMC, and other committees, including charters, meeting organization, planning, and scheduling • Set up and maintain project-specific MS Teams • Update study items in CTMS, including milestones and study contacts • Liaise with Procurement and confirm vendors are on the approved vendor list • Support vendor setup, contracts, and management activities • Ensure the safety TORO is drafted and the safety database is set up before FPI • Support ancillary supply vendor setup • Review project-level vendor invoices • Review time entry weekly • Assist with completion of the OOS Log • Maintain the Action/Decision Log with input from department leads • Triage new user system access requests and complete user access reviews • Complete final financial reconciliation, including site, vendor, and sponsor invoices and payments • File and maintain study-level documents in the eTMF

🎯 Requirements

• BA/BS in the science/health care field, or nursing degree, preferred, or equivalent combination of education and experience • At least 4 years of clinical research coordinating experience or experience working in a contract research organization (CRO), pharmaceutical, or biotechnology company is preferred • Competent computer skills including MS Office Suite • Experience working with eTMF and EDC systems is preferred • Capable of performing job responsibilities with minimal training and oversight; sufficient experience and knowledge to serve as a mentor to more junior CRCs • Customer service oriented • Demonstrated good communication skills (written and verbal) • Attention to detail • Ability to plan and organize information and activities as directed by a Study Manager or team member • Able to resolve routine problems and elevate issues appropriately • 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 • Ability to lift, carry, and move 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

🏖️ Benefits

• Remote work (United States)

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