Project Management

The project manager assumes responsibility for each individual project once the project is assigned to his team. Coordination and steering immediately start up with the delegation of responsibilities to all stakeholders. Important aspects of liaison with the sponsor remain with the project manager. Optimal communication is maintained with the sponsor ensuring that study specific objectives are met.
The entire project team works for the study feasibility analysis, constant communication flow with sponsor, designing of Bioavailability/Bioequivalence study, ensure safety of volunteers/patients involved in study, inputs on setting up suitable Bio-analytical analysis method, applying suitable statistical analysis, meeting project timelines and deliver reports according to regularity compliance

Project Management Responsibilities as a Follows:
 – Setting up project timelines for the projects awarded to Auriga
 – Conduct meeting with sponsor for their technical queries
 – Study updates to sponsor, Regulatory and Ethics committee
 – Arranging training on regulatory update on BA/BE studies
 – Budgeting of BA/BE study and negotiation with sponsor
 – Documents’ review before finalization of the project
 – Cite aspects of project management from budget management to operational delivery
 – Develop contracts and subject enrollment strategies to minimize costs and stay on budget
 – Regular effective meetings with all stake holders of the project throughout the study peiod.
 – Utilize proven audit tools to establish a practical approach for maintaining regulatory compliance
 – Implement best practices for managing misconduct and fraud to protect patient safety and avoid – -costly regulatory and legal action
– Develop efficient processes for data management and adverse event reporting to streamline compliance requirements
 – Utilize proven quality control tools to collect and measure performance data and implement process improvements
 – Identify and prioritize financial, technical, and legal risks to ensure project success