The Clinical Project Manager provides leadership and end-to-end management of clinical trials, ensuring alignment with Sponsor expectations and organizational objectives. This role combines strategic oversight with hands-on project execution, fostering cross-functional collaboration and delivering studies on time, within budget, and in compliance with applicable regulations and quality standards. Key Responsibilities Leadership & People Management Lead, motivate, and manage assigned team members by setting clear objectives and monitoring performance to ensure the achievement of organizational goals in a diverse and inclusive environment. Identify training needs to enhance team performance and support career development. Project Planning & Delivery Oversee the full lifecycle of clinical projects, including planning, timelines, budget management, and vendor coordination, as well as the review and preparation of budget amendments. Ensure the execution of clinical trials in compliance with agreed timelines and quality/quantity standards set with the Sponsor. Escalate any deviations related to quality, timelines, and budget to the direct supervisor. Business Development & Client Engagement Contribute to the preparation of client proposals and support negotiations during the contracting phase. Act as the primary point of contact for stakeholders, providing input on feasibility, study design, budget development, and progress reporting (resources, budget, and timelines). Lead periodic Sponsor meetings/calls and finalize and approve related minutes. Clinical Operations Oversight Coordinate all clinical services involved in the project (Medical Writing, Start-up, Data Management, Biostatistics, Feasibility, Monitoring) throughout the study lifecycle, ensuring adherence to SOPs, budget, timelines, and applicable regulations. Oversee monitoring activities in line with the monitoring plan, budget, and Sponsor agreements, ensuring timely delivery of monitoring visit reports. Deliver study-specific training (Protocol, CRF, etc.) to the internal study team and, where required, to site staff. Participate in Investigator Meetings and teleconferences, including preparation of meeting minutes. Study Documentation & Trial Master File Management Manage Sponsor-provided study documentation and coordinate the preparation of core documents required for regulatory submissions and study approval. Prepare and maintain Study Manuals, Trial Master File (TMF), and Investigator Study File (ISF), ensuring proper distribution to participating sites. Quality, Compliance & Risk Management Manage audit and inspection findings, ensuring appropriate corrective and preventive actions (CAPA) are implemented. Ensure proper handling of Serious Adverse Events (SAEs) in accordance with protocol and applicable regulations. Implement and maintain procedures for clinical trial management in compliance with GCP, ISO, MDD/MDR, and all applicable regulations. Report major protocol, GCP, and SOP violations to Quality Assurance and Top Management. Requirements Bachelor's Degree or higher in Life Sciences, Pharmacy, Biotechnology, Nursing, Medicine, Biomedical Sciences, or a related scientific discipline. Minimum 5 years of experience in clinical research, including at least 2 years in clinical project management or study leadership roles. Experience in Pharmaceutical Clinical Trials and/or Medical Device Clinical Investigations. Demonstrated experience managing clinical studies from start-up through close-out, including oversight of timelines, vendors, study sites, and project deliverables. Experience working within a CRO environment is considered a strong advantage. Demonstrated knowledge of ICH-GCP, ISO 14155, applicable regulatory requirements, and clinical quality standards. Key Skills Strong knowledge of ICH-GCP, ISO 14155, EU MDR requirements, and applicable clinical trial regulations and quality standards. Excellent project management skills, with the ability to oversee multiple studies, timelines, budgets, and priorities simultaneously. Strong leadership and team management capabilities, with the ability to motivate and coordinate cross-functional teams. Excellent stakeholder management and communication skills, including interaction with Sponsors, investigators, vendors, and internal teams. Ability to identify, assess, and mitigate project risks while ensuring delivery of study objectives. Strong organizational, problem-solving, and decision-making skills in a dynamic clinical research environment. Financial acumen, including budget planning, forecasting, and resource management. Commitment to quality, regulatory compliance, and patient safety. Professional proficiency in English, with the ability to communicate effectively in an international clinical research environment and produce high-quality scientific and technical documentation. Systems & Technology Advanced experience working with EDC/eCRF platforms and oversight of study data collection activities. Knowledge of eTMF systems, including oversight of TMF completeness, quality, and inspection readiness. Proficiency in Clinical Trial Management Systems (CTMS) for study planning, tracking, and reporting. Knowledge of Microsoft Office Suite (Word, Excel, PowerPoint, Outlook), including preparation of project reports, metrics, and study presentations. Experience using project management and collaboration tools (e.g., Microsoft Teams, SharePoint, Smartsheet, Monday.com, or similar platforms). Ability to analyze study performance metrics, timelines, risks, and resource allocation through relevant reporting tools and dashboards. Familiarity with remote monitoring technologies, electronic document management systems, and digital collaboration platforms #J-18808-Ljbffr
