Regulatory and Start Up Specialist at IQVIA

Madrid, Community of Madrid, Spain

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Not SpecifiedCompensation

Entry Level & New GradExperience Level

Full TimeJob Type

UnknownVisa

Clinical Research, PharmaceuticalIndustries

Requirements

Spanish language fluency
1-year clinical research experience within submissions (or equivalent combination of education, training, and experience)
Home-based role capability

Responsibilities

Serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary
Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables, and project timelines
Perform start-up and site activation activities according to applicable regulations, SOPs, and work instructions
Distribute completed documents to sites and internal project team members
Prepare site regulatory documents, reviewing for completeness and accuracy
Ensure accurate completion and maintenance of internal systems, databases, and tracking tools with project-specific information
Review and provide feedback to management on site performance metrics
Review, establish, and agree on project planning and project timelines
Ensure monitoring measures are in place and implement contingency plans as needed
Inform team members of completion of regulatory and contractual documents for individual sites
Review, track, and follow up on the progress, approval, and execution of documents, including regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents, in line with project timelines
Provide local expertise to SAMs and project team during initial and ongoing project timeline planning
Perform quality control of documents provided by sites
May have direct contact with sponsors on specific initiatives

Skills

Key technologies and capabilities for this role

Site ActivationRegulatory SubmissionsSOPsClinical ResearchProject TimelinesDocument ReviewQuality ControlTracking ToolsSpanishInformed Consent FormInvestigator Pack

Questions & Answers

Common questions about this position

Is this a remote position?

Yes, this is a home based role.

What language skills are required for this role?

Spanish language fluency is required.

What experience is needed for this position?

1-year clinical research experience within submissions is required, or an equivalent combination of education, training and experience.

What is the company culture like at IQVIA?

IQVIA values diversity, inclusion, and belonging, creating a culture where employees bring their authentic selves and diverse experiences to empower innovation in healthcare.

What salary or compensation does this role offer?

This information is not specified in the job description.

IQVIA

Advanced analytics and clinical research services

About IQVIA

IQVIA provides advanced analytics, technology solutions, and clinical research services specifically for the life sciences industry. Their services utilize extensive data resources and technology to create connections within healthcare, allowing clients to gain insights that help speed up the development and marketing of new medical treatments. This process is facilitated by their IQVIA Connected Intelligence™ system, which offers quick and flexible insights. IQVIA stands out from competitors by focusing on patient privacy, employing various technologies to protect individual data. The company's goal is to enhance healthcare outcomes by supporting biotech, pharmaceutical, and medical device companies, as well as researchers and government agencies, in understanding diseases and advancing medical science.

Durham, North CarolinaHeadquarters

1998Year Founded

$3,526MTotal Funding

POST_IPO_EQUITYCompany Stage

Cybersecurity, Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Rapid advancement of cancer vaccines may disrupt traditional clinical research models.

Proliferation of disparate technological solutions causes technology overload in clinical trials.

Generative AI technologies face challenges in adoption due to data privacy concerns.

Differentiation

IQVIA leverages advanced analytics and big data for life sciences solutions.

The company offers privacy-enhancing technologies to protect individual patient data.

IQVIA's AI Assistant provides rapid, actionable insights for healthcare and life sciences.

Upsides

Increased adoption of decentralized clinical trials enhances patient-centric study designs.

AI-driven drug discovery accelerates identification of potential drug candidates.

Expansion of telemedicine facilitates remote patient monitoring and data collection.

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