Project Specialist - Clinical Registry Coordinator

IQVIA, Inc.; Reading; On-site; GBP 30,000 - 60,000

Job description

Essential Functions:

• Provides clinical registry support, oversight and/or accountability for one or more clinical trials.
• Gathers content and integration requirements for registration records - establishes expectations for dataset content and structure. Sets timelines and follows up regularly to ensure delivery of all clinical trial disclosure milestones.
• 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.
• Responsible for tracking, reporting and documentation of disclosure records and associated documents in tools and systems used by the clinical registry group.
• 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.
• Assists business partners, external partners, and local operating companies in maintaining accurate and correct (source) data relevant to the disclosure process.
• Ensures timely resolution of planning issues to ensure compliant delivery of the disclosure planning.
• Ensures deliverables are on time.

Education and Experience Guidelines:

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