Sharing a Vision to Drive Healthcare Forward
Healthcare is an industry designed to help humans. As a global community, we continuously invest and commit to advancing human health. To deliver value and real outcomes. To rise to the challenge to find the next breakthrough by making the most of increasingly limited resources.
We are inspired by the potential ...
Read more about this company
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. – Set timelines and follow-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
Assisting 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.