Our client is a leading global provider of Pharmaceuticals. This company is comprised of professionals who are passionate about their role in bringing their Medicine to their customers worldwide.
This position is responsible for coordinating and ensuring timely start-up activities, and maintaining communication with local Health Authorities. You will work closely with the global study team and local stakeholders to ensure that study start-up activities align with country commitments and are completed on schedule.
Job Description
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- Collaborating with the Team Lead and Country Head Portfolio/ Cluster Head Portfolio to support the country's Study Start-Up strategy.
- Working with the Country/Cluster Head Portfolio, Portfolio Team Leads, and the global study team to ensure that timelines and deliverables align with country commitments.
- Taking accountability for timely start-up activities, starting from country allocation to achieving the milestone, indicating readiness to initiate site activities. Closely communicate with local Institutional Review Boards/Independent Ethics Committees and Health Authorities.
- Ensuring that all study start-up activities are completed on schedule, including preparing IRB/IEC submission packages, reviewing Informed Consent Forms, and coordinating with Regulatory Affairs/CTA Hub for Health Authorities submissions, when necessary.
- Preparing and finalizing local submission packages for IRB/IEC, CTA Hub (Europe: as per new EUCTR guidelines), and applicable Health Authorities, including amendments, Investigator's Brochures (IBs), Development Safety Update Reports (DSURs), and Clinical Study Reports (CSRs).
- Collaborating with local and global stakeholders to respond promptly to deficiency letters and coordinate reportable events and notifications to IRB/IEC and Health Authorities, as needed.
- Ensuring the accuracy, quality, and timely maintenance of country Trial Master File (TMF) documents during the study start-up phase, ensuring inspection readiness.
- Adhering to financial standards, prevailing legislation, ICH/GCP guidelines, IRB/IEC requirements, Health Authority regulations, and standard operating procedures (SOPs).
- Implementing innovative and efficient processes aligned with strategic goals.
- Supporting feasibility studies in collaboration with the Feasibility Manager, Site Partnership Manager, and the global study team. If assigned, lead site selection, in coordination with the Portfolio Team Lead and Clinical Project Manager.
Requirements
- A degree in a scientific or health-related field.
- Experience in clinical trials and project management.
- Minimum 5 years experience in clinical operations (project management/monitoring clinical trials).
- Fluent in English.
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