Senior Clinical Research Associate (m/f) en Optimapharm - full-service mid-sized European CRO

Senior Clinical Research Associate (m/f)
Optimapharm - full-service mid-sized European CRO
Barcelona, 26 Nov.
Location: Company’s office in Spain (Barcelona or Palma de Mallorca) and remote.

Your responsibilities:

Monitor study sites independently according to the protocol monitoring guidelines, SOPs, GCP ICH guidelines (selection, initiation, monitoring and close-out)
Manage assigned sites by regular contacts with site personnel to ensure site compliance, adequate enrolment and understanding of study requirements
Support study sites by acting as a liaison between the site and study sponsor and/or clinical vendors
Prepare accurate and timely trip reports
Independently perform CRF review; query generation and resolution against established data review guidelines or data management systems as applicable
Preparation of corrective and preventive (CAPA) plans for issues identified during monitoring activities and pro-active follow of each, individual CAPA until timely resolution
Maintenance and management of the relevant project tracking systems as prescribed in the project plans
Participate in company-required training programs, timely and accurate completion as well as ongoing maintenance of Personal Training Record

Numero de vacantes: 1

Ventajas sociales o económicas
Who we are?

Established in 2006, OPTIMAPHARM is a full-service mid-sized European CRO, that provides tailored solutions and has high-level expertise in managing trials across Europe, with unrivaled access to patients. Our operational excellence and customer-focused approach have led to us achieving a 95% repeat business level.

In 2020, OPTIMAPHARM acquired Syntax for Science, one of the top 5 Spanish full-service CROs specialized in data management and statistics, and since then, significantly strengthened its presence in the key European markets of Spain and Portugal.

Having offices across Europe, as well as having a network of preferred partners, OPTIMAPHARM is well qualified to manage trials in Europe, Israel and the US, supporting Biotech, Pharmaceutical and Medical Devices companies in reaching large patient populations in various indications whilst achieving competitive start-up timelines at competitive prices.

What do we offer?

Working in a successful company that’s growing and changing every day
Working with a highly experienced team of the clinical research professionals
International projects and professional growth
Competitive salary and performance bonus
Premium Health insurance
Training opportunities
Work from home
Flexible work hours
Summer work schedule

Who are we looking for?

Qualifications and Experience:

University degree, preferably in medical or life sciences. Individuals with university degree in biotechnical, technical, bio medicinal, social, or humanistic sciences must have nursing education or other relevant healthcare college degree.
At least 3 - 4 years of independent clinical trial monitoring experience, experience in oncology studies is an advantage
High level of knowledge of ICH GCP Guidelines, knowledge of regulatory requirements and a strong interest in clinical research
Experience in Quality Systems and audit/inspection visits
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
Very good 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 would be advantageous (position requires up to 30% of travel)

Estudios mínimos
Inglés nivel Perfecto.
Experiencia mínima
4 años
Disponibilidad para viajar
El 40% del tiempo laboral

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