Senior Clinical Research Associate - Spain

optimapharm-doo; Madrid; Presencial; EUR 45.000 - 60.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Performance bonus

Referral bonus

Flexible work hours

Work from home allowance

Health insurance

Training and development program

Well-being programs

Employee engagement programs

Descripción de la vacante

Optimapharm is seeking an experienced CRA to join our global clinical research team. Based in Spain (Madrid or Barcelona), you will monitor sites, ensure patient safety, data integrity, and compliance with GCP/ICH guidelines across oncology, neurology, and infectious disease studies.

You will work independently within a matrix environment, collaborate with investigators, manage site visits, perform CRF review, and contribute to trial budgets and site contracts while advancing your career in a

Formación

• University degree in medicine, pharmacy, dentistry, or equivalent
• Fluent in local language and English (written and spoken)
• Knowledge of GCP/ICH guidelines and regulatory requirements
• Ability to read, analyze, and interpret scientific/technical journals
• Excellent verbal and written communication skills
• Current, valid driver's license

Responsabilidades

• Perform routine site visits independently across the region
• Manage assigned sites with regular contact to ensure enrolment and compliance
• Independently perform CRF review and resolve queries
• Identify risks and retraining opportunities for site personnel
• Prepare CAPA plans for issues identified during monitoring and follow up until resolution
• Prepare EC submission documents and translations, and perform other tasks as instructed
• Negotiate study budgets with investigators and assist with site contracts
• Support administration of site payments per project instructions

Conocimientos

Clinical research

GCP/ICH knowledge

English fluency

Regulatory understanding

Computer proficiency

Educación

University degree in medicine/pharmacy/dentistry or equivalent

Descripción del empleo

Location: Spain (Madrid or Barcelona based)

Who we are?

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

At Optimapharm, you'll have the opportunity to work on diverse and meaningful projects that help bring innovative therapies to patients worldwide. As part of our international team, you'll 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.

We're 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.

What do we offer?

• Working in a successful company that’s 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 allowance
• Additional Health Insurance
• Shopping discounts
• Employee engagement programs
• Well-being initiatives
• Training and development program

Who are we looking for?

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 driver’s license

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 elevate 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 until timely resolution
• Prepare documents required for EC submissions and notifications, translate study-related documents (where applicable), and perform other tasks as instructed
• 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, 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 candidate’s 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.