Regulatory and Start-up Specialist, IQVIA Biotech, Spain at IQVIA

Madrid, Community of Madrid, Spain

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Not SpecifiedCompensation

Entry Level & New Grad, Junior (1 to 2 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, Clinical Research, PharmaceuticalIndustries

Requirements

B Sc degree in Health Sciences or related field
1-2 years clinical research experience
Experience in EUCTR and CTIS submission procedures and Country Informed Consent adaptation for Spain
Preferred experience in Site Contract Negotiation with Spanish sites
In-depth knowledge of clinical systems, procedures, and corporate standards
Good negotiating and communication skills
Effective communication, organizational, and interpersonal skills
Ability to work independently and to effectively prioritize tasks
Ability to manage multiple projects
Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines

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 plan as needed
Inform team members of completion of regulatory and contractual documents for individual sites
Review, track and follow up the progress, the approval and execution of documents, 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 on-going 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 DocumentsEUCTRCTISSOPsClinical ResearchEthics SubmissionsInformed Consent FormInvestigator PackProject Timelines

Questions & Answers

Common questions about this position

What qualifications and experience are required for this role?

A B Sc degree in Health Sciences or related field is required, along with 1-2 years of clinical research experience, experience in EUCTR and CTIS submission procedures, and Country Informed Consent adaptation for Spain.

What key skills are needed for the Regulatory and Start-up Specialist position?

Candidates need good negotiating and communication skills, effective communication, organizational, and interpersonal skills, ability to work independently, prioritize tasks, manage multiple projects, and knowledge of GCP/ICH and applicable regulatory guidelines.

Is this a remote position or does it require working in an office?

This information is not specified in the job description.

What is the salary or compensation for this role?

This information is not specified in the job description.

What does IQVIA's company culture emphasize?

IQVIA emphasizes diversity, inclusion, and belonging to empower its mission to accelerate innovation for a healthier world.

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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