šÆ 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 patientsā lives. Optimapharmās key priorities are our people and consistently exceeding our clientās 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 Senior Clinical Research Associate to join our Clinical Operations team in Greece and support us in making a tangible difference to project sponsors and benefiting patients and their families all around the world.
š What do we offer?
- Working in a successful company thatās growing and developing every day
- Being part of a clinical research team that transforms science into hope for patients
- International projects and professional growth
- Performance bonus
- Referral bonus
- Flexible work hours
- Work from home days
- Company car or car allowance
- Additional Health Insurance
- Employee engagement programs
- Well-being initiatives
- Training and development program
š Who are we looking for?
š¼ Qualifications and Experience
- University degree in medicine, pharmacy, dentistry, or equivalent
- At least 4 years of independent clinical trial monitoring experience (oncology, neurology, infectious diseases experience is a plus)
- Strong interest in clinical research and excellent understanding of the clinical trial process
- Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
- Fluent in local language and English, both written and verbal
- Computer proficiency is mandatory
- Ability to read, analyze, and interpret common scientific and technical journals
- Excellent verbal and written communication skills
- Excellent interpersonal and negotiation skills
- Ability to work with minimal supervision, pro-active
- Affinity to work effectively and efficiently in a matrix environment
- Excellent numerical skills and reasoning ability
- A current, valid driverās license
š Your responsibilities
- Perform routine site visits independently, including pre-study, initiation, interim monitoring and closeout visits across the region
- Manage assigned sites by regular contact with site personnel to ensure site compliance, adequate enrolment and understanding of study requirements
- Independently perform CRF review; generate and resolve queries against established data review guidelines or data management systems as applicable
- Identify and escalate potential risks and identify retraining opportunities for site personnel
- Prepare corrective and preventive (CAPA) plans for issues identified during monitoring activities and pro-active follow-up on each individual CAPA until timely resolution
- Prepare documents required for EC submissions and notifications, translate study-related documents (where applicable), and perform other tasks as instructed by the supervisor
- Independently negotiate study budgets with potential investigators and institutions and assist with the execution of site contracts as applicable
- Support administration of site payments in accordance with relevant project instructions
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 and note that only shortlisted candidates who meet the requirements will be contacted for the further selection process.
Compensation is competitive and final offers will reflect each candidateās experience, skills, and qualifications.
Disclaimer: Unsolicited CVs sent to Optimapharm (Talent Acquisition Team, Hiring Managers or any other OPT employee) by recruitment agencies will not be considered for this role. Optimapharm follows a direct sourcing strategy and collaborates exclusively with selected recruitment partners when external support is required.
