Senior Clinical Research Associate Spain

Location: Spain (Madrid or Barcelona based)

Optimapharm is a mid-sized global Contract Research Organisation turning science into hope through agile patient-focused clinical development.

At Optimapharm youll have the opportunity to work on diverse and meaningful projects that help bring innovative therapies to patients worldwide. As part of our international team youll collaborate with experts across multiple disciplines gain exposure to a broad range of therapeutic areas and contribute to research that makes a real difference.

With colleagues in 26 countries and operations in more than 40 countries we combine global reach with the agility collaboration and supportive culture of a mid-sized organisation. Here your expertise is valued your growth is encouraged and your work has a visible impact.

Were searching for a CRA who is motivated by quality driven by purpose and eager to contribute to innovative clinical research that changes lives. At Optimapharm your dedication is rewarded with meaningful growth opportunities exposure to diverse studies and the support needed to reach your full potential.

• Working in a successful company thats growing and developing every day
• Being part of a clinical research team that transforms science into hope for patients
• International projects andprofessional growth
• Performance bonus
• Referral bonus
• Flexible work hours
• Work from home allowance
• Additional Health Insurance
• Shopping discounts
• Employee engagement programs
• Well-being initiatives
• Training and development program

• 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 drivers license

• 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

If you would be interested in joining the Optimapharm team please send your CVand 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 candidates 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.