Clinical Trials Regulatory Officer – Maintenance Associate at IQVIA

Bratislava, Bratislava Region, Slovakia

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Not SpecifiedCompensation

Junior (1 to 2 years)Experience Level

Full TimeJob Type

UnknownVisa

Clinical Research, PharmaceuticalsIndustries

Requirements

Good knowledge of clinical research domain and applicable regulatory requirements/guidelines
Good knowledge of Clinical Systems (CTMS, TMF, Workflows etc)
Expert with MS Excel and good knowledge of MS Office applications and Spotfire reports
Strong Analytical skills
Strong communication and collaboration skills
Ability to work on multiple projects/tasks balancing competing priorities

Responsibilities

Support study delivery during the maintenance phase of the study
Work alongside MLs and CTRMs to complete all necessary maintenance and regulatory activities for selected studies or multi-protocol programs
Understand the scope of work, budget, and resources to ensure smooth project execution
Support, setup, and maintenance of various clinical systems
Manage and utilize study dashboards
Analyze data and monitor study metrics and compliance
Prepare project status reports and presentation materials for internal project team and customer meetings
Connect with key internal stakeholders for the project
Support resource request processes
Assist study teams in maintenance activities
Act as a back-up for the Maintenance Lead (ML) when necessary
Support EAC management when applicable
Escalate quality or compliance issues, delays, and risks to relevant stakeholders
Implement solutions for complex process issues
Participate in initiatives to support the CTRO-MA community and aid personal development

Skills

Key technologies and capabilities for this role

Clinical TrialsRegulatory ManagementStudy MaintenanceClinical SystemsData AnalysisStudy DashboardsProject Status ReportsStakeholder ManagementCompliance MonitoringRisk Escalation

Questions & Answers

Common questions about this position

Is this position remote or home-based?

Yes, this is a home-based position in EMEA.

What skills are required for the Clinical Trials Regulatory Officer – Maintenance Associate role?

Required skills include good knowledge of clinical research and regulatory requirements, good knowledge of clinical systems like CTMS and TMF, expertise with MS Excel, strong analytical skills, and strong communication and collaboration skills.

What training and development opportunities are available?

The company provides training, mentorship from experienced team members, ongoing support, and career development paths to roles like Maintenance Lead, CTRM, or positions in startup and trial conduct.

What is the salary or compensation for this role?

This information is not specified in the job description.

What makes a strong candidate for this position?

A strong candidate has good knowledge of clinical research regulations, clinical systems, MS Excel expertise, strong analytical and communication skills, and the ability to manage multiple projects while balancing priorities.

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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