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PV RA MW Coordinator
Remote, India
Job Id R-01239424
Job Type Full time
Category Clinical Research
Job Description
• Provides critical support and coordination in the review of safety and regulatory publishing documents, ensuring timely and accurate processing upon receipt.
• Plays a key role in maintaining document quality by tracking safety and regulatory publishing data, ensuring seamless uploading into internal and/or external electronic trial master files.
• Takes responsibility for maintaining the confidentiality and integrity of sensitive information, meticulously ensuring the redaction of Commercially Confident Information and Personal Data for regulatory publishing.
• Assists in the maintenance of licenses across projects, ensuring compliance with IT Security standards and facilitating smooth operations for users.
• Takes charge of coordinating and facilitating project meetings, ensuring effective communication and collaboration among team members.
• Demonstrates exceptional organizational skills by managing project-specific training, setting up and maintaining program files, and ensuring audit readiness.
• Protects subject and client confidentiality by identifying and redacting confidential identifiers according to local requirements, providing necessary retraining, and escalating any recurring issues to PPD Data Privacy.
• Performs accurate and efficient data entry into various databases and tracking systems, including PPD’s budget management system, ensuring project timelines are not compromised.
• Takes ownership of overseeing expenses and managing translations, ensuring adherence to budget parameters and cost-efficiency.
• Assists in the essential task of archiving regulatory publishing documents and submissions, contributing to the seamless flow of information and compliance.