Niraj Pandey Email & Phone Number

Performed site selection visits and negotiated study budgets with potential investigators as per the sponsor requirement-Critical document collection-Carried out translation works for the study-related documentation – ICF, patient dairies, etc.-Supporting EC and regulatory submissions-Participated and presented in Investigator meeting's-Conducted site initiation visits including finalizing site-specific enrollment plans-Site motivational visits were conducted for low recruiting sites to meet the enrollment timelines.-Routine monitoring visits and sending of follow-up letters to sites and submitting the visit reports to the project manager in time.-Training study staffs on protocol and other study procedures including use of eCRFs –Oracle RDC, IVRS, laboratory techniques and documentation.-Performed study drug accountability and reconciliation.-Resolving Data Management queries-Complete understanding of AEs and SAE reporting structure and its reconciliation-Updating study trackers to project management in timely manner-Overall study management and troubleshooting-Study team training on ongoing basisSpecialties•Clinical trials (Phase I, II, and III)•Regulatory Submissions and compliance (Global & Domestic projects)•Medical Writing•BA/BE studiesEDC and e-CRF (ClinPhone, InFrom 4.5, iMedidata RAVE 5.6) , Oracle RDC online IVRS/ IWRS