Emerald Clinical Trials is a global, full-service Contract Research Organization dedicated to advancing clinical research through scientific expertise and operational excellence. They are seeking an experienced Clinical Project Manager to lead global and regional clinical trials, particularly in renal, ensuring successful project execution and compliance with regulatory guidelines.
Responsibilities:
- Provide strong, independent leadership for assigned clinical projects, ensuring successful execution
- Serve as the primary point of contact for clients, vendors, and internal stakeholders
- Oversee study management activities, including site selection, initiation, monitoring, and closeout
- Develop and maintain study timelines, budgets, and project plans, ensuring adherence to scope
- Mitigate risks and proactively address challenges to keep projects on track
- Ensure compliance with ICH-GCP, regulatory guidelines, and company SOPs
- Manage vendor relationships and study-specific contracts
- Provide mentorship and guidance to junior project team members
- Support proposal development, bid defense meetings, and business growth initiatives
- Participate in internal and external project team meetings to ensure alignment and success
Requirements:
- 5–7 years of project management experience in clinical research, preferably in a CRO or pharmaceutical environment
- Strong Nephrology clinical trial experience is required
- Proven expertise in budget management, forecasting, and contract oversight
- A proactive, solutions-oriented mindset with excellent communication and leadership skills
- Strong knowledge of ICH-GCP and regulatory requirements (FDA, TGA, EMA, etc.)
- Proficiency in Microsoft Office (Word, Excel, PowerPoint, Adobe Acrobat)
- Ability to manage multiple priorities in a fast-paced, global environment
- A degree in a relevant scientific, healthcare, or project management field
- Prior experience in clinical site management and CRA roles is preferred