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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in managing clinical trials, including feasibility assessments, regulatory submissions, and compliance with ICH-GCP guidelines. Proficient in project management, risk management, and budget oversight while ensuring effective communication with stakeholders.
Highest-signal resume keywords
Clinical Trial ManagementCTIS SubmissionsRegulatory ComplianceProject ManagementStakeholder Management
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical Trial ProcessesBudget ManagementRisk ManagementStudy Documentation ReviewKPI Monitoring
Soft Skills
Excellent CommunicationStakeholder Management
Tools & Technologies
CTIS
Industry Keywords
Life SciencesPharmacyNursingICH-GCP GuidelinesCRO Coordination
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Coordinate feasibility assessments and interactions with investigators, experts, and key stakeholders.
- Lead the preparation, start‑up, implementation, and operational oversight of clinical trials.
- Support regulatory submissions and study maintenance activities through **CTIS**.
- Review and oversee country‑specific study documentation to ensure regulatory compliance.
- Monitor study KPIs, metrics, and dashboards to track study performance.
- Coordinate external monitoring providers and administrative support vendors.
- Organize and lead study meetings, ensuring appropriate documentation and follow‑up of action items.
- Monitor patient recruitment, site engagement, and overall study progress.
- Identify study risks and implement mitigation plans to ensure successful delivery.
- Manage study budgets and track financial performance.
- Provide support to investigational sites through on‑site visits when required.
- Oversee study close‑out activities, including site closure, database lock, and study archiving.
Requirements
What you’ll need- - Degree in **Life Sciences, Pharmacy, Nursing, or a related scientific field**.
- - Previous experience as a **Clinical Trial Manager, Local Study Manager, Clinical Project Manager, or equivalent role**.
- - Strong knowledge of **clinical trial processes**, including start‑up, conduct, and close‑out.
- - Experience with **CTIS submissions** and regulatory processes in Europe.
- - Good understanding of **ICH‑GCP guidelines** and clinical trial regulations.
- - Experience coordinating CROs, vendors, and investigational sites.
- - Strong project management, risk management, and budget management skills.
- - Excellent communication and stakeholder management abilities.
- - Fluent English (written and spoken).
Benefits
Comp & perks- **Why Join Us?**
- At Excelya, we combine passion for science with enthusiasm for teamwork to redefine excellence in healthcare.
- Here’s what makes us unique.
- We are a young, ambitious health company representing 900 Excelyates, driven to become Europe’s **leading mid-size CRO **with the **best employee experience**. Our **one-stop provider service model **offering full-service, functional service provider, and consulting enables you to evolve through diverse projects. Working alongside preeminent experts, you will help improve scientific, operational, and human knowledge to enhance the patient’s journey.
- **Excelling with care** means benefiting from an environment that values your natural talents, pushes boundaries with audacity, and nurtures your potential, allowing you to contribute fully to our shared mission.
