About PPD
PPD, an internationally reputed pharmaceutical contract research organization and manufacturing body that established its journey in 1993. This company serves the purposes in the areas of medicinal chemistry, in vivo pharmacology, biology, toxicology, Process R&D, cGMP manufacturing, analytical development and custom synthesis
The firm has accreditations like iso 9001:2008. It has also animal facilities authorized by Indian authorities. Syngene serves for 331 clients globally including start-up companies. Large pharma/biotech, chemical, animal health and nutritional companies from 25 years.
The company focuses on client satisfaction areas of safety, quality, integrity and ethics. Recently it made an agreement with GSK in the area of advanced drug delivery system. Received PMDA accreditation, expanded collaboration with many MNC. This has been awarded with CMO Leadership awards by life science leader magazine in Newyork.
About the Job
Experience : Bachelors degree with 0-1 year experience
Location : Bengaluru
Role
Candidate required to maintain the supports during the study specific documentation and systems including but not limited to: tracking of project specific training requirements, system access management, study team lists and tracking of project level activity plans in appropriate system.
system support (i.e. GoBalto & eTMF) and related activities.
Required to complete the allocated tasks are performed on time, within budget and to a high quality standard.
According to the specific role (Central or Local), coordinates, oversees and completes functions on assigned trials activities detailed on the task matrix and Proactively communicates any risks to project leads.
Internal, Country, Departmental and Investigator file reviews to be done as assigned and documents findings in appropriate system.
Required to Supports RBM activities.
Able to timely performs administrative tasks on assigned trials including but not limited to: performing (e)TMF reviews, timely processing of documents sent to Client (e)TMF as assigned, providing documents and reports to internal team members performing mass mailings and communications as needed.