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Clinical Project Manager
hace 2 horas
We are seeking a Clinical Project Manager to oversee and coordinate clinical research projects and studies. This role ensures that studies are executed efficiently, within budget, on schedule, and in compliance with regulatory standards, ICH GCP, and internal quality systems . Depending on experience, the Clinical Project Manager may take primary responsibility for lower complexity studies such as bioequivalence, observational, or real-world evidence (RWE) studies . Key Responsibilities Ensure studies are adequately resourced, managed, and executed in line with budget, timelines, and quality standards . Develop and maintain project plans , defining scope, objectives, and deliverables in collaboration with internal stakeholders. Participate in multi-disciplinary project teams, overseeing clinical operations and development activities. Prepare, review, and approve essential study documents, including protocols, patient information sheets, CRFs, clinical study reports, and publications . Manage internal clinical operations and oversee vendor and CRO performance , ensuring milestones are met, quality standards maintained, and risk mitigation strategies are implemented. Responsible for clinical trial budgeting , including supporting contract negotiations and financial tracking for vendors, sites, and CROs. Support vendor selection and evaluation for projects under management. Prepare for and manage audits and inspections from regulatory authorities or quality assurance teams , ensuring all study documentation, including TMFs, site files, and monitoring reports , is audit‑ready. Ensure operational excellence across studies by implementing risk‑based approaches in all clinical activities. Provide regular project updates to management, including identifying risks, workstream dependencies, resource needs, and key milestones. Build and maintain strong relationships with investigators, clinical, and external partners. Required Qualifications Degree in biological, health sciences, or related discipline . Relevant experience in clinical research and/or project management , such as monitoring or clinical operations. Knowledge of Good Clinical Practice (GCP) and certificate preferred. Understanding of clinical project management principles and operational processes. Strong interpersonal, communication, and presentation skills ; able to interact effectively with internal and external stakeholders. Strategic thinking, problem-solving, and ability to consider multiple perspectives when developing solutions. Ability to work collaboratively in cross‑functional teams . Highly organized, able to manage multiple tasks and track key project deliverables. Why This Role is Exciting Opportunity to make a positive impact on patient outcomes through clinical research. Flexible working arrangements and a collaborative team environment. Access to professional development, learning opportunities, and mentorship. Supportive culture that values empathy, curiosity, humility, and optimism. Benefits and programs designed to support physical, emotional, and financial wellbeing . #J-18808-Ljbffr
