Senior Project Specialist

Job description

**This position is listed on behalf of a partner company, which manages all applications and next steps. Our partner is looking for a Senior Project Specialist based in the United States.** Join a specialized clinical research team dedicated to advancing ophthalmic product development through high-quality clinical trials and effective project coordination. As a Senior Project Specialist, you will support Project Managers and multidisciplinary study teams throughout the clinical study lifecycle, from study start-up to financial reconciliation and document closeout. You will play a key role in maintaining accurate study documentation, coordinating meetings, tracking project timelines, and ensuring compliance with established procedures. Working closely with clinical, data management, medical, statistical, and vendor teams, you will help keep projects organized, transparent, and on schedule. Your expertise will also contribute to budget tracking, vendor coordination, risk management, and the smooth execution of study operations. In addition to managing complex project activities, you will mentor and train junior Project Specialists, helping strengthen team capabilities and operational excellence. This remote opportunity is ideal for an experienced clinical research professional who thrives in a collaborative environment and wants to make a meaningful contribution to innovative ophthalmic research. ### Accountabilities - Coordinate internal and sponsor-facing project meetings, including kick-off and investigator meetings, by preparing invitations, agendas, meeting materials, and minutes. - Set up and maintain project-level information in Clinical Trial Management Systems (CTMS), including study contacts, milestones, timelines, and other essential project data. - Draft Project Management Plans (PMPs), Risk Management Plans (RMPs), electronic Trial Master File (eTMF) plans, and other project documentation for Project Manager review. - Prepare internal and external project status reports, progress updates, and other communications to support effective stakeholder oversight. - Coordinate project team training and monitor compliance with applicable study requirements, internal procedures, and documentation standards. - Prepare monthly forecasts of revenue units and project activities, tracking budgets, forecasted hours and visits, and invoicing for Project Manager review. - Maintain project timelines in collaboration with the Project Manager and relevant study team members, identifying potential delays and escalating issues as appropriate. - Organize and manage Data Safety Monitoring Board (DSMB), Data Monitoring Committee (DMC), and other committee activities, including charters, meetings, planning, and scheduling. - Establish and maintain project-specific Microsoft Teams workspaces to support collaboration, communication, and document access. - Coordinate with Procurement to verify that vendors are approved and assist with vendor onboarding, contract setup, ongoing management, and ancillary supply arrangements. - Ensure the safety Terms of Reference (TORO) is drafted and the safety database is established before First Patient In (FPI). - Review vendor invoices at the project level and conduct weekly time-entry reviews to support accurate financial tracking and billing. - Assist with maintaining the Out-of-Scope (OOS) Log and manage the Action/Decision Log in collaboration with department leads, including Clinical Leads, Data Managers, Medical Monitors, Medical Writers, and Statisticians. - Triage system access requests for new study personnel and complete periodic user access reviews to maintain appropriate access controls. - Perform final financial reconciliations covering site, vendor, and sponsor invoices and payments. - Maintain complete and up-to-date study documentation in the eTMF, including protocols, study plans, vendor management records, and project communications. - Mentor and train junior Project Specialists, share best practices, and provide operational guidance to support consistent team performance. - Provide backup project coordination and communication support when Project Managers or Associate Project Managers are unavailable. ## Requirements - Bachelor's degree in a scientific or healthcare-related field, a nursing degree, or an equivalent combination of education and relevant experience. - At least four years of clinical research coordination experience or relevant experience within a Contract Research Organization (CRO), pharmaceutical company, or biotechnology organization is preferred. - Experience with clinical trial documentation and study coordination, including familiarity with clinical study start-up and ongoing study management activities. - Proficiency in Microsoft Office applications and the ability to manage multiple project documents, reports, timelines, and tracking tools. - Familiarity with electronic Trial Master File (eTMF) systems and Electronic Data Capture (EDC) platforms is preferred. - Ability to perform responsibilities independently with minimal training and supervision, exercise sound judgment, and resolve routine operational issues while escalating more complex concerns appropriately. - Demonstrated communication skills, both written and verbal, with the ability to coordinate effectively with sponsors, vendors, project teams, and cross-functional stakeholders. - Strong organizational skills and attention to detail, particularly when maintaining study records, monitoring timelines, reviewing invoices, and tracking project deliverables. - A customer-service-oriented approach and the ability to build positive, productive relationships across multidisciplinary teams. - Ability to plan and organize information and activities in accordance with direction from Study Managers, Project Managers, and other team members. - Demonstrated leadership potential and the ability to mentor, train, and support less experienced clinical research professionals. - Flexibility, initiative, and a proactive approach to managing competing priorities in a dynamic clinical research environment. **Physical requirements:** - Ability to sit, type, use a computer, and review written or digital materials for extended periods. - Sufficient hand and finger dexterity, visual acuity, hearing, and verbal communication ability to perform routine computer-based and collaborative work. - Ability to move around conference or meeting locations and periodically stand, walk, stoop, kneel, or crouch for extended periods as required. - Ability to lift, carry, or move light to medium weights of approximately 10–35 pounds when necessary. ## Benefits - **Remote work:** Work remotely from within the United States. - **Professional development:** Opportunities to expand clinical research expertise and strengthen project management capabilities. - **Career advancement:** Potential for professional growth within clinical operations and clinical project management. - **Meaningful work:** Contribute to clinical research programs supporting ophthalmic product development and improved healthcare outcomes. - **Collaborative environment:** Work alongside multidisciplinary professionals across clinical operations, data management, medical writing, statistics, and other specialized functions. - **Leadership opportunities:** Mentor junior team members and help promote consistent processes, knowledge sharing, and operational excellence. - **Varied project experience:** Gain exposure to study start-up, regulatory documentation, vendor management, financial oversight, risk planning, and clinical trial coordination.