• Coordinated with the clinical trial management staff to support the execution and monitor clinical trials. • Participated in study planning and set- up activities including vendor management, project management, Kept track of study timelines, budget and contract process, reviewed and approved invoices and served as first point of contact for any vendor related issues.• Assisted in the preparation of study concept documents, clinical protocols, amendments, consent forms, study guides, monitoring plans, (e)CRFs, and subject tracker, regulatory submissions and publications.• Performed quarterly QC of TMF to ensure all the required documents are captured and classified as per Amgen TMF Index and maintained TMF audit ready.• Worked with TMF support group and reached out to respective departmental representatives to alert upcoming milestones in TMF and assisted with closing the milestones.• Coordinated study-level investigational product arrangements, accountability and reconciliation and authored Investigational Product Instructional Manual • Monitored study sites, reviewed and acknowledged monitoring visit reports, and held responsible for study start-up activities and site management • Coordinated activities associated with study close-out including LLR, Database lock, snapshot, TFL’s, CSR write up and TMF archival.• Worked with Clinical Research Study Manager, Early Development Lead and Principal Investigator(s) to discuss active patients and assisted in the conducting DLRM.• Provided input to and maintained administrative systems (eClinical) and EDC systems (Medidata RAVE)• Provided extensive clinical site operational support by answering protocol- specific questions, identifying eCRF data collection and query resolution.