Sr. Clinical Project Manager

Cosmo Technologies Ltd, a pharmaceutical company based in Dublin and part of the Cosmo Group, is currently seeking a highly skilled and experienced Sr. Clinical Project Manager to join our dynamic team on a permanent basis.

In this role, directly reporting to the Clinical Operation Manager, you will be responsible for the planning, execution, and management of clinical trials sponsored by Cosmo, ensuring compliance with regulatory requirements, budget, and timelines. This role requires strong leadership, strategic thinking, and the ability to oversee the activity of different vendors, such as CROs and laboratories.

The ideal candidate will be well-versed in clinical trial management and have experience covering the therapeutic area of Gastrointestinal (GI) diseases and/or Oncology.

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 sites 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.
• Provide strategic input into trial design, feasibility assessment, and operational strategy.
• Conduct regular project status updates and present findings to senior management.

Qualifications and 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 system.
• Ability to work in a fast-paced, deadline-driven environment.
• Willingness to travel as needed.
• European Citizen.

Cosmo Pharmaceuticals is an equal opportunity employer.