Clinical Project Lead (BBBH30700) Dublin, Republic of Ireland
For 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 Position
* Provide 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 Person
* Bachelor’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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