• Served as a contact document coordinator for all clinical trial documentation. • Supported management of patient data file room to ensure ready to audit status. • Engaged in cross functional TMF and Inform consent forms for patient enrolled clinical trials. • Reviewed, approved and distributed revised SOP to various cross functional departments to ensure timely training and GCP compliance

• Worked in manual and ERP based document management system and supported document. revision and periodic life cycle management. • Collaborated with reviewer, technical writers, approvers, and training on all new and current. document revision workflow to ensure timely revision of documents. • Maintain data base of all documents such as SOP, BPR, Specification, protocols, and TDS. • Supported document retrieval, submission to external archival document warehouse like Iron Mountain and access. • Assisted training coordinator and continuous training for users of the revised documents and associated change control.