Company Jobs

Participate independently in the planning of analysis and data presentation to be used, initially in conjunction with the mentoring medical writer.

To effectively review visit reports as per Protocol and ICON and Sponsor SOPs and to ensure the quality of reports are of the highest standards , errors are minimized and that issues are escalated as appropriate

University / College Degree (Life Science preferred), or certification in an allied health profession from an appropriate accredited institution

Advanced knowledge of Data Management processes and systems. Solid understanding of clinical drug development process and production of Data Management deliverables

Responsible for the companys drug surveillance program including the necessary follow-up, assessment, and relatedness to product on adverse reaction reports, oversight of safety in clinical trials and post marketing programs.

Review and check the quality of the site and study documents to submit with IRB/EC central, local, hospital committee and HA/RA.

This role serves as a key contributor to regulatory operations by ensuring the accuracy, integrity, and compliance of regulatory information used for global submissions, registrations, product maintenance, and post-market activities.

Line management responsibilities for staff members. For direct and indirect reports, may participate in and manage activities related to department staff operations such as interviewing and selection, job description preparation, professional development

Perform setup activities including CRF creation, edit check specification creation, and User Acceptance Testing.