Regulatory and Start Up Manager, IQVIA Biotech

IQVIA; Valencia; A distancia; EUR 60.000 - 80.000; Jornada completa

Descripción de la vacante

A global clinical research organization is seeking an experienced professional to manage site activation and regulatory activities for clinical studies. Candidates should have a Bachelor's in Life Sciences and over 7 years of relevant experience. Strong negotiation, communication, and project management skills are essential. This role is home-based with annual travel commitments.

Formación

• 7+ years of experience in a scientific or clinical environment.
• Strong ability to manage complex projects effectively.
• Deep understanding of clinical trial processes and regulatory standards.

Responsabilidades

• Oversee site activation and maintenance for clinical projects.
• Collaborate with teams to ensure project compliance.
• Prepare regulatory submissions and manage approvals.

Conocimientos

Negotiation skills

Communication skills

Interpersonal skills

Project management

Regulatory knowledge

Leadership skills

Organizational skills

Educación

Bachelor's Degree in Life Sciences

Descripción del empleo

Job Overview

Direct and manage the delivery of all required site activation, maintenance, and regulatory activities for selected studies or multi-protocol programs, including pre-award activities, scope of work, budget, and resources.

Home-based role, requiring yearly travel for bid-defense meetings and study kick-offs.

Essential Functions

• Oversee the execution of site activation (including pre-award/bid defense activities) and/or maintenance for assigned projects in accordance with the RSU site activation strategy, adhering to project timelines. Develop, implement, and maintain the Management Plan according to the Scope of Work and Project Plan, resolving project-related issues as needed. Ensure collaboration across Regulatory & Site Activation teams, including communication with regions and countries, to deliver the project scope in compliance with the RSU Management Plan. Create and review technical and administrative documentation to support business development and enable study initiation and maintenance. Provide regulatory and scientific support to facilitate efficient clinical trial processes and ensure regulatory compliance. Oversee multi-regional and multi-protocol programs during start-up and maintenance phases. Determine regulatory strategies and expectations for submissions and approvals.
• Identify regulatory challenges and offer practical solutions during bid processes and site activation. Assess and interpret the regulatory landscape, disseminate regulatory intelligence, and support study and company-wide initiatives. Manage operational strategies for maintaining clinical study approvals, reviewing contracts, and essential documents. Collaborate with Quality Management to uphold quality standards. Mentor colleagues, ensure accurate data entry in internal systems (e.g., CTMS), and maintain project timelines. May lead in developing client relationships and deliver training or presentations. Involved in budget planning and review activities.

Qualifications

• Bachelor's Degree in Life Sciences.
• At least 7 years of relevant experience in a scientific or clinical environment, including international roles. Equivalent education, training, and experience accepted.
• Strong negotiation and communication skills.
• Excellent interpersonal skills and team-oriented mindset.
• Proven ability to manage complex projects and deliver results on time and within quality standards.
• Deep understanding of the regulated clinical trial environment and drug development process.
• Proficiency with systems and technology to achieve work objectives.
• Good regulatory and technical writing skills.
• Knowledge of GCP, ICH guidelines, and regulatory standards.
• Leadership skills with the ability to motivate and mentor teams.
• Strong organizational and planning abilities.
• Independent judgment and risk management skills.
• Effective presentation skills.
• Ability to build and maintain effective relationships with colleagues, managers, and sponsors.
• Excellent understanding of study financial management.
• Ability to manage multiple projects and priorities effectively.

IQVIA is a leading global provider of clinical research, commercial insights, and healthcare intelligence. We aim to accelerate medical development and improve patient outcomes worldwide. We value diverse talent, curiosity, and innovation. Join us in making a difference.

This job posting is active and accepting applications.