Precision for Medicine

• Provides regulatory guidance throughout the clinical development life cycle
• Compile, coordinate and review applications to Regulatory Authorities
• Develops and/or reviews documents intended for submission to the Regulatory Authorities and/or Ethics Committees

• Provides regulatory guidance throughout the clinical development life cycle.
• Develops and/or reviews documents intended for submission to the Regulatory Authorities and/or Ethics Committees to assure compliance with regulatory standards.
• Serve as representative of Global Regulatory Affairs at project team meetings with both external and internal customers

• Monitor and own the progress of clinical studies at investigative sites.
• Coordinate all necessary activities required to set up and monitor a study.
• Ensure that clinical studies are conducted, recorded, and reported per protocol, SOPs, ICH-GCP, and all applicable regulations and standards.

• Accountable for clinical project delivery, oversight of all functional departments, and ensuring agreed timelines, scope, cost and quality.
• Serve as the primary point-of-contact liaison with the client to provide excellent customer service, including participation in proposal activities and client presentations.
• Prepare project status updates for clients and management; identifying key deliverables and performance metrics of success and escalation.

• The Medical Director serves as the project physician and provides medical and scientific expertise to project teams, ensuring data accuracy and patient safety.
• Support Business Development by participating in the RFP process, preparing medical considerations for proposals, and participating in bid defense meetings.
• Review and revise protocols, case report forms, training materials, project specific tools, analysis plans, study designs, clinical trial reports and new drug applications.

• Monitor and own the progress of clinical studies at investigative sites.
• Coordinate activities to set up and monitor a study.
• Train and mentor junior staff members.

As Clinical Trial Manager, you will lead CRAs and oversee clinical aspects of studies across multiple countries. You will ensure timeline adherence and scope, whilst ensuring quality delivery. Management and operational delivery of the clinical elements within a trial including site selection, start-up, and data cleaning activities. Identify challenges to study timelines/deliverables and offer creative action plans to the team/sponsor.