Descripción de la oferta
About the Company
INSUD PHARMA operates across 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 (APIs), finished dosage forms (FDFs), and branded pharmaceutical products, adding value for human and animal health.
INSUD PHARMA’s activity is organized into three synergistic business areas: Industrial (Chemo), Branded (Exeltis), and Biotech (mAbxience), with over 9,000 professionals in more than 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.
Role Overview
We are looking for a Junior Clinical Trial Assistant (Junior CTA) to join our Clinical, Preclinical, and Biopharmaceutics team. This is a great opportunity for someone looking to start and grow their career in clinical research within an international and highly regulated environment.
In this role, your main focus will be the management and maintenance of the Trial Master File (TMF/e‑TMF), ensuring that essential study documentation is complete, accurate, and compliant throughout all study phases.
As you develop your expertise, you will progressively take on broader operational and administrative responsibilities to support the successful execution of our clinical and preclinical projects.
Responsibilities
Support the set‑up, maintenance, and completeness of the TMF/e‑TMF across all study phases
Collect, review, and track essential documents in line with internal procedures and applicable regulations
Identify documentation issues and schedule escalating them to the relevant team members when needed
Prepare confidentiality agreements and coordinate protocol signature processes
Compile and archive CRO quotations
File study approvals from Ethics Committees and Health Authorities
Maintain tracking tools and administrative records for assigned studies
Support study payments, including invoice processing, supplier registration, payment requests, and approvals
Follow up on administrative aspects of studies, such as CROs, insurance, monitoring activities, export certificates, authorizations, and notifications
Support IMP, non‑IMP, and placebo shipments to CROs, under supervision
Assist with project kick‑off and study start‑up activities
Communicate progress, updates, and issues to the relevant team members in a timely manner
Qualifications
Education: Diploma, Secondary Education, vocational training, or equivalent. Specific training in clinical research or pharmaceutical operations will be a plus.
Languages: Basic to intermediate English is required. Communicative Spanish is preferred. Other languages are a plus.
Experience: Entry‑level position. Previous exposure to clinical research, pharmaceutical operations, or regulated environments through internships, academic experience, or early professional roles will be highly valued. Experience in document management, tracking activities, or administrative support will be an asset.
Knowledge: Basic understanding of GCP, ICH guidelines, and TMF/essential document management. Good computer literacy, especially in Word, Excel, and PowerPoint.
Travel: Occasional travel may be required (less than 5%).
Additional: At least 1–2 years of experience in a similar position is desired.
Benefits
Flexible start hours Monday to Friday (full 40‑hour work week)
Attractive salary package
Company cafeteria free of charge
Benefits and Savings Club
Development plans and internal mobility policy
And much more
Commitment to Equal Opportunities
The InsudPharma group is aware that business management must align with the needs and demands of society, and therefore assumes the commitment to equal opportunities and treatment between men and women, as established in current regulations – Organic Law 3/2007, and we do not discriminate against anyone based on ethnicity, religion, age, sex, nationality, marital status, affective or sexual orientation, gender identity or expression, disability, or any other personal or social circumstance.
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