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).
• Address authority questions during CTA evaluations.
• 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.