Clinical Research Associate
Es posible que un gran número de candidatos se presenten a este puesto, así que asegúrese de enviar su CV y su solicitud lo antes posible.
INSUD PHARMA operates throughout the entire pharmaceutical value chain, providing specialized knowledge and experience in scientific research, development, manufacturing, sales, and marketing of a wide range of active pharmaceutical ingredients (API), finished dosage forms (FDF), and branded pharmaceutical products, adding value to both human and animal health.
INSUD PHARMA's activity is structured into three synergistic business areas: Industrial (Chemo), Branded (Exeltis), and Biotech (mAbxience), with more than 9,000 professionals in over 50 countries, 20 state-of-the-art facilities, 15 specialized R&D centers, 12 commercial offices, and over 35 pharmaceutical subsidiaries, serving 1,150 clients in 96 countries worldwide. INSUD PHARMA believes in innovation and sustainable development.
Collaborate with Clinical Development Leaders to execute assigned trials aligned with the product development plan.
Take ownership of trial execution, reporting, and evaluation, ensuring compliance with GCP and applicable regulations.
Support clinical trial activities according to ICH/EMA/FDA and other relevant guidelines.
oversee contracted activities (cost, quality, timelines).
Protocol, ICF, monitoring oversight, study report).
Oversee monitoring documentation (e.g., MVRs), SDV quality, and site readiness/compliance.
Oversee training of site staff on protocols, safety reporting, and GCP.
Coordinate internal CHEMO activities linked to trial conduct (e.g., Partner with cross-functional teams (Pharm Dev, Regulatory, PV, Project Management) to support execution.
University degree in a Life Sciences discipline (mandatory)
~2+ years in a similar CRA/clinical trial oversight role
~ Experience in global clinical development and trial implementation (site selection/management, monitoring activities)
~ Remote and on-site monitoring exposure, including risk-based monitoring (RBM)
~ Strong understanding of ICH-GCP, FDA, EMA, and local regulatory requirements
~ Skilled in identifying/documenting/escalating AEs/SAEs
~ Fluent English required
Spanish (communicative level) is a plus; Comfortable with Microsoft Office for reporting/documentation
Flexible entry schedule from Monday to Friday (full-time, 40 hours).
#Permanent contract
#Co-payment on voluntary health insurance.
#We will continue with an in-person/virtual interview depending on availability and as we agree; the process may include one or two interviews, and depending on the type of process, there may also be some sort of test.
Follow us on social media like LinkedIn/Instagram and stay tuned for any openings we post: the opportunity to become a new Insuder is waiting! xohynlm