Salin Routray

• Prioritized tasks to meet tight deadlines, pitching in to assist others with project duties.
• Coordinate the startup process provide regular updates to all functions concenerd
• Collect review and submit documents for ethics and regulatory review and approval
• Prepare core packages of site document for drug release to clinical site.
• Develop and negotiate site contracts and budget communicate with project teams.
• Develop country/site specific startup timelines.

Maintain the project schedule and resource changes with Project manager. taking care of the resource plan with functional leads. prepare monthly dashboard report. Responsible for

Reporting any issue in project delivery team .

- Manage study documents with eTMF classifier role. filing and tracking weekly study site reports .

- Tracking the missing reports with CRA .

- Assisting in the document management (including document template creation, collection, review, processing and tracking up to eTMF filing) for all documents in the scope of agreed processes/activities or within the scope of GSDM throughout the study duration.

- Assisting in Investigator Payment Processing, Site budget validation and related activities.

• Collaborated with other departments to enforce data accuracy and enhance productivity.
• Closely worked with Project leaders on Project management task while gaining expertise and developing a sense of ownership during the project life cycle, contributing to achievement of study deliverables.

• Created data management plans and provided input on study designs.
• Participated in quality assurance reviews to verify accuracy and reliability of data.
• Built complex data analysis reports and provided timely feedback to stakeholders.
• Assisted with database upgrades and migrations by performing user acceptance testing.