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Alimentiv 2

Clinical Project Manager

Raleigh-Durham, North Carolina · Remote · Full-time, Permanent · Clinical Study Delivery - Clinical Study Management - Project Management

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About the role

Clinical ResearchStatisticsProject ManagementComplianceCommunication
Alimentiv is a global CRO with a singular focus: advancing therapies for patients with gastrointestinal diseases. GI is our WHY and for more than 30 years that purpose has driven our scientific rigour, operational excellence, and deep therapeutic expertise, including supporting more than 70% of IBD compounds in development. We operate as a private, profit-with-purpose company, channeling our commercial success back into scientific research, technology, and our people. With approximately 700 people across multiple countries and three service lines, we are growing deliberately, and the capability of our leaders and our organization is central to how we get there. If you want to do meaningful work, build something real, and invest back in research that changes lives — we want to meet you! Job Overview We are seeking a motivated and detail-oriented Clinical Project Manager to oversee the planning, execution, and successful delivery of clinical research projects. In this role, you will coordinate cross-functional teams, manage project timelines and deliverables, ensure regulatory compliance, and maintain strong relationships with sponsors and clients. The ideal candidate will possess excellent communication, organizational, and problem-solving skills, with a collaborative approach to achieving project objectives. This is a home-based opportunity with occasional travel. Key Responsibilities Lead the planning, execution, monitoring, and completion of assigned clinical research projects, ensuring project objectives and deliverables are achieved. Coordinate cross-functional project teams to ensure activities comply with applicable regulations, industry guidelines, corporate policies, and quality standards. Oversee project operations, budgets, regulatory requirements, and patient safety to maintain operational and financial integrity throughout the project life cycle. Manage the development, maintenance, and appropriate disposal of essential clinical study documents, data, equipment, and tools, including protocols, SOPs, informed consent forms, and case report forms (CRFs). Assign, track, and oversee interdisciplinary activities, including site monitoring, database development, data collection, adverse event management, statistical analysis, and clinical study reporting. Serve as the primary point of contact for sponsors and clients, proactively managing expectations, resolving project-related issues, and maintaining effective communication. Organize and facilitate project meetings, prepare investigator updates, and provide regular project progress and status reports to relevant stakeholders. Support site and patient recruitment strategies, stakeholder training initiatives, and the development of study-related communication materials. Participate in regulatory submissions, audits, third-party vendor selection, and other activities required to support successful project delivery. Monitor team performance, project milestones, and deliverable quality to ensure alignment with sponsor expectations, project requirements, and regulatory standards. Skills & Qualifications Bachelor's degree in a relevant field, preferably Health Sciences, Clinical Research, or a related discipline. 1–3 years of experience in clinical study management, with exposure to clinical research project coordination and execution. Strong understanding of clinical research processes, regulatory requirements, quality standards, and study documentation practices. Excellent project management and organizational skills, with the ability to coordinate multiple tasks, track deliverables, and meet project deadlines. Strong written and verbal communication skills, with the ability to interact effectively with sponsors, clients, investigators, and cross-functional teams. Demonstrated ability to build collaborative working relationships, encourage teamwork, and coordinate interdisciplinary project activities. Exceptional attention to detail, with a commitment to maintaining accuracy, compliance, and high-quality project outcomes. Self-motivated and results-oriented, with strong problem-solving skills and the ability to proactively identify and address project challenges. Commitment to continuous learning, professional development, and adapting to evolving project and organizational requirements. Fluency in English, including reading, writing, and speaking, with the ability to work effectively in a home-based environment and travel occasionally as required.