Requirements: English
Company: Exeltis
Region: Madrid , Community of Madrid
Position: Clinical Trial Manager
Location: Madrid .
Want to know more?
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 (API), finished dosage forms (FDF), and branded pharmaceutical products, adding value to human and animal health.
The activities of INSUD PHARMA are 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 more than 35 pharmaceutical subsidiaries, serving 1,150 customers in 96 countries worldwide. INSUD PHARMA believes in innovation and sustainable development.
What are we looking for?
Clinical Trial Oversight & Leadership Responsibilities:
- Collaborates with Clinical Project Managers and clinical operations team to drive project success.
- Develops Informed Consent Forms, Clinical Monitoring Plans, and other study-related materials.
- Prepares and leads routine CRA team meetings and attends study team meetings.
- Ensures all study team members and sites are trained on study documents and processes.
- Acts as a resource and point of escalation for protocol and process questions.
- Ensures the Trial Master File is set up and reviewed routinely for compliance.
- Confirms completeness of Trial Master File throughout the study and final reconciliation before close-out.
- Collaborates with the Clinical Trial Assistant (CTA) to ensure all study systems are functional.
- Understands Project Management principles related to quality, timelines, budgets, and vendor management.
- Demonstrates advanced leadership abilities and contributes to department initiatives and business development.
- Assists with selection of central IRB and oversees progress with assigned CRAs.
- Monitors study and site-level IRB submissions and approvals.
- Co-monitors with CRAs as applicable.
Financial Activities:
- Tracks actual spending compared to the financial forecast for the study-level operational budget.
- Develops standard study-level site budgets and ensures consistency with the overall study budget.
- Oversees clinical research-related payments to sites and vendors.
- Performs reconciliation of site payments at study close-out.
Study Level Performance Management:
- Provides oversight of CRAs to ensure timelines and deliverables are achieved.
- Collaborates with other Clinical Trial Managers to align country timelines.
- Provides study-specific training, guidance, and leadership to clinical research staff.
- Reviews and approves clinical invoices against approved scopes of work and budgets.
Requirements:
- Bachelor''s or equivalent degree in a scientific or health-related field, nursing qualification, or relevant experience. A Master''s degree is advantageous.
- Proficiency in English; additional language skills are a plus.
- Over 4 years of experience in clinical research and clinical monitoring, with prior experience working for a Sponsor and CRO.
- Extensive knowledge of clinical research practices, including ICH-GCP requirements, drug/device development processes, regulatory compliance, study start-up, and coordination.
- Proven track record in clinical study management and coordination.
- Strong leadership capabilities.
- Excellent strategic thinking, organizational, and communication skills.