Clinical Project Lead (BBBH30700) Dublin, Republic of IrelandFor over a century and five generations, this family-owned company has been dedicated to improving lives through innovative healthcare solutions around hormonal treatments for women and men’s health.With a history of pioneering breakthroughs, this company has grown into a global operation over the past 20 years. They have a direct presence in 22 countries and a multicultural team of 1,500 employees worldwide, having doubled in size in recent years. Generating $500 million in annual revenues, their growth is rooted in our unwavering commitment to innovation, diversity, and understanding what truly matters to patients and their families.The PositionProvide input on clinical trial synopses (timelines, feasibility, costs).General project management duties in the given clinical trial (timeline, costs and quality) according to the commercial and regulatory needs of the company.Manage CRO/vendor selection, contracting, and oversight.Coordinate clinical study protocol preparation and documentation.Oversee site selection, qualification, and investigator meetings.Ensure compliance with regulatory requirements (e.g., EudraCT, ClinicalTrials.gov).Track project status and ensure adherence to agreed milestones.Manage study budgets and verify invoices.Ensure continuous quality oversight with risk-based monitoring.Oversee Trial Master File (TMF) management and archiving.Ensure Good Clinical Practice (GCP) compliance.Support pharmacovigilance reporting (e.g., DSUR, PSUR).Act as the primary contact for internal teams and external vendors.Prepare and deliver presentations to senior management.Collaborate with cross-functional teams globally.The PersonBachelor’s Degree (Science discipline preferred).5+ years in clinical trial management and vendor oversight.Strong knowledge of GCP and compliance standards.Experience across multiple therapeutic areas is an advantage.Strong project management and problem-solving abilities.Excellent communication (oral and written).Ability to multitask and work independently.Strategic thinking with a results-driven approach.Proficiency in MS Office (Excel, PowerPoint, Word).To learn more about this role apply online or contact Trisha Bracken on +353 87 344 9559 for a confidential discussion.
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