Project Specialist - Clinical Registry Coordinator

IQVIA Argentina; Reading; On-site; GBP 35,000 - 55,000; Full time

Job summary

An established industry player is seeking a dedicated Clinical Registry Specialist to support clinical trials and ensure compliance with disclosure requirements. This role involves managing submissions to global registries, tracking disclosure documents, and collaborating with various partners to maintain accurate data. The ideal candidate will have a strong background in clinical research, project management skills, and a passion for improving patient outcomes. Join a dynamic team committed to advancing healthcare and making a positive impact on global health through innovative medical treatments.

Qualifications

• 3+ years of experience in a clinical development environment required.
• Strong project and vendor management skills are essential.

Responsibilities

• Provide clinical registry support for clinical trials.
• Track and report disclosure records and associated documents.

Skills

Project Management

Vendor Management

Clinical Research

Data Management

Education

Bachelor’s degree in health or science discipline

Tools

Clinical Trial Management Systems

Job description

Essential Functions :

1. Provides clinical registry support, oversight and/or accountability for one or more clinical trials.
2. Gathers content and integration requirements for registration records – Establishes expectations for dataset content and structure. – Set timelines and follow-up regularly to ensure delivery of all clinical trial disclosure milestones.
3. Responsible for submission of approved documents and content to registries worldwide, either directly such as for clinicaltrials.gov or the EU clinical trial register, or indirectly by providing to the local operating company staff for subsequent submissions to local registries.
4. Responsible for tracking, reporting and documentation of disclosure records and associated documents in tools and systems used by the clinical registry group.
5. Responsible for planning, routing, and follow-up of disclosure documents with business partners, external partners, and local operating companies, ensuring timely and compliant delivery of these documents.
6. Assisting business partners, external partners, and local operating companies in maintaining accurate and correct (source) data, relevant to the disclosure process.
7. Ensures timely resolution of planning issues to ensure compliant delivery of the disclosure planning.
8. Ensures deliverables are on time.

Education and Experience Guidelines:

1. A minimum of 3 years of relevant pharmaceutical/scientific experience in a clinical development environment (pharmaceutical, medical device, CRO or other clinical development service organization) is required.
2. Bachelor’s degree in health or science discipline with experience in clinical research.
3. Project management and vendor management skills.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com