Purpose/Objective of the job

Support the team and the Global Submission Management Clinical Trial Book of Work and manage the EU portal in light of the new EU Clinical Trial Regulation.

Key Responsibilities and Major Duties

• Support the GSM-CT team in optimally preparing and distributing initial CTAs and Substantial amendments to country applicants for submission to Competent Authorities and Ethics Committees.

Apply for EUDRACT/UTN numbers for studies with EU participation and ensure appropriate communication of the obtained numbers to the Protocol Managers.

Assist GSM-CT Team with the general preparation of the Clinical Trial Application packages and duplication of forms

Index certain documents in TMF

Assist GSM-CT Team with our Regulatory Information Management System (HA submission and approval Tracking system) by creating events/activities/registrations/running reports etc

Utilizes technology effectively to support the clinical trial application submission process. Proficient use of CTMS, Tracking systems, Excel trackers, maintain departmental SharePoint

Support GSM-CT in creation of End of Trial and tracking, as well as distribution of CSRs to Country Applicants.

Contributes to other requirements as appropriate to allow proper functioning of the GSM-CT.

• Support implementation of the EU CT REG Portal and manage the uploading of the clinical trial documentation in the EU portal
• Contribute to the Country Requirements Repository by collecting and sharing additional country requirements.

Requirements:

• Demonstrates a general understanding of the clinical research process (EU knowledge is an asset).
• Proficient use of other applications and software (Excel, Powerpoint, eConferencing, etc) to fully support processes.
• Demonstrates flexibility to work simultaneously on projects of different therapeutic areas and different countries. Communicates effectively using excellent verbal and written skills with both internal and external key stakeholders; coordinates information and document flow to and from both internal and external customers.
• Works well in a team environment, collaborates effectively with internal groups and demonstrates a "can do" approach. Utilizes effective problem-solving approaches and independently follow-up and resolves outstanding issues, within deadlines to achieve key deliverables.
• Exhibits flexibility and willingness to develop new skills by being receptive to new systems and processes. Seeks to identify and implement best practices.
• Analytical and detailed-orientated skills in tracking and analyzing numerical and other data