Qualitis SA, part of Optimapharm Group, requires for immediate employment a Clinical Study Leader (Position Code: Q/CSL/CL), who will be fully involved in the clinical trials of an International Pharmaceutical Company in Athens.
Our Company provides an excellent benefits package, including:
- Competitive Salary
- Company Car/Mobile Phone/Private Health Insurance
- Annual Bonus
Job responsibilities mainly include:
- Develops and manages comprehensive clinical trial timelines and metrics and ensures that they are met.
- Oversees that clinical trial progress is reported and tracked and assures that proper documentation is maintained and archived.
- Prepares and implements trial-specific training programs and materials for clinical research staff (CRAs/CTAs).
- Assists the planning of regulatory/ethics committee approval process.
- Provides guidance and mentoring to clinical research staff and investigational sites.
- Reviews the site visit reports.
- Develops, tracks and updates clinical trial budgets.
- Ensures audit-ready condition of clinical trial documentation. Participates in the planning of quality assurance activities and coordinates resolution of audit findings
- Attends meetings to discuss handling/improving people planning process.
The ideal candidates should fulfill the following qualifications/requirements:
- Hold a University and Postgraduate Degree in Health Sciences.
- A minimum of four (4) years of experience as a Senior CRA or one (1) year of experience in a Managerial role within the field of Clinical Research in the Pharmaceutical Industry/CRO Sector.
- Excellent knowledge of ICH GCP requirements.
- Exceptional writing and presentation skills.
- Excellent computer literacy with the MS Office Suite.
- Ability to multitask and work in a fast-paced environment.
- Ability to travel on a regular basis.
Candidates should send their CVs in English indicating the position code, at info@qualitis.gr
