Job Title: Senior Clinical Project Manager
A highly experienced and skilled Senior Clinical Project Manager is required to join our client, a pharmaceutical company based in Dublin. The successful candidate will be responsible for the planning, execution, and management of clinical trials, ensuring compliance with regulatory requirements.
Key Responsibilities:
* Lead the planning and execution of clinical trials from initiation to completion.
* Develop and manage study budgets, timelines, and resources.
* Oversee protocol development, regulatory submissions, and site selection.
* Ensure adherence to Good Clinical Practice (GCP), ICH guidelines, and regulatory requirements.
* Act as the primary point of contact for internal and external stakeholders.
* Manage and mentor cross-functional teams, ensuring efficient communication and collaboration.
* Monitor study progress, identify risks, and implement mitigation strategies.
* Review and approve study-related documentation, including investigator brochures, informed consent forms, and clinical study reports.
Requirements:
* Bachelor's or Master's degree in Life Sciences, Pharmacy, or a related field.
* Minimum of 5-7 years of experience in clinical trial management within the pharmaceutical, biotech, or CRO industry.
* Strong knowledge of clinical trial regulations (FDA, EMA, ICH-GCP).
* Proven track record of managing multi-center, global clinical trials.
* Excellent project management, leadership, and problem-solving skills.
* Strong interpersonal and communication abilities to liaise with various stakeholders.
* Proficiency in using different EDC systems.
* Ability to work in a fast-paced, deadline-driven environment.