Study Leader

Optimapharm is a leading, mid-sized, full-service CRO working across Europe and North America to deliver new therapies to improve and save patients' lives. Optimapharm's key priorities are our people and consistently exceeding our client's expectations.

With 26 strategically located offices, Optimapharm operates in 40+ countries, giving unrivaled access to Patients and Investigators in all countries in Europe and North America.

In-depth expertise and long-standing experience, combined with a flexible and collaborative approach, allow optimization of design and planning; through its strong track record of delivery excellence and committed and stable project teams, Optimapharm has secured a high level of repeat business over the years.

We are looking for a Study Leaderto join our teamin Greece and support an International Biopharmaceutical Company in Athens with Non-Interventional Studies (FSP model).

• Working in a successful company that's growing and developing every day
• Working with a highly experienced team of clinical research professionals
• Professional growth
• Performance bonus
• Referral bonus
• Training opportunities
• Work from home days
• Additional Health Insurance

• Bachelor's degree and/or equivalent, preferably in biological science or healthcare-related field
• MSc/PhD in a scientific discipline would be considered a plus
• Minimum 3 years of experience in Clinical Operations
• Experience in Project Management
• Understanding of multiple aspects within Clinical Operations and/or Medical Affairs will be advantageous, as well as extensive knowledge of the latest technical and regulatory requirements
• High level of knowledge of ICH GCP Guidelines
• Fluent in local language and English; both, written and verbal
• Computer proficiency is mandatory
• Excellent verbal and written communication skills
• Excellent organisational and analytical skills
• Excellent decision-making skills
• Good change management skills
• Affinity to work effectively and efficiently in a matrix environment
• A current, valid driver's license would be advantageous

• Lead study execution at assigned investigational sites, ensuring all study commitments, timelines, and quality standards are met for Non-Interventional Studies (NIS)
• Oversee site lifecycle activities including site identification, setup, initiation, monitoring, closure and documentation archiving, specifically for NIS studies
• Manage regulatory submissions, ensuring timely delivery of required applications and documents to authorities and hospitals
• Customize, review, and complete study agreements within required timelines
• Coordinate investigator selection based on site capability and competence, and maintain regular communication with investigators on recruitment and study progress
• Develop and lead patient recruitment strategies, collaborating with investigators and the national coordinating investigator
• Collaborate on forecasting study needs (timelines, resources, recruitment, budget, materials)
• Oversee and support monitoring activities, including reviewing monitoring visit reports, providing guidance to monitors, and performing co-monitoring and QC visits
• Maintain and quality-check study documentation by managing electronic systems, ensuring timely uploads, QC checks and compliance
• Monitor study data and financials and ensure accurate study-related payments.

By joining our fast-growing and prosperous team, you will have an excellent opportunity for further personal growth and career development.

If you would be interested in joining the Optimapharm team, please send your CV in English and note that only shortlisted candidates who meet the requirements will be contacted for the further selection process.