Study Leader (FSP model) Greece
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Job Location:
Monthly Salary:
Posted on:
12 hours ago
Vacancies:
1 Vacancy
Job Summary
Who are we
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. Optimapharms key priorities are our people and consistently exceeding our clients 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 ourteamin Greece and support anInternational Biopharmaceutical Company in Athens with Non-Interventional Studies (FSP model).
What do we offer
- Working in a successful company thats 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
Who are we looking for
Qualifications andExperience
- Bachelors 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 drivers license would be advantageous
Yourresponsibilities
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 financialsand 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.
Key Skills
- Python
- C/C++
- Fortran
- R
- Data Mining
- Matlab
- Data Modeling
- Laboratory Techniques
- MongoDB
- SAS
- Systems Analysis
- Dancing
About Company
Optimapharm is a globally operating, leading, mid-sized, full-service CRO aiming to deliver new therapies to improve and save patients’ lives
