Pranitha K Email and Phone Number

SUMMARY:● Dedicated Clinical Data Manager who has successfully worked in Phase I-III studies for the last 7+ years.● Dominant therapeutic areas are Oncology, Cardiovascular, Immunology, and Pain management. KEY STRENGTHS:● Excellent CDM skills across the complete data management process flow from Study Setup, Study Conduct, and Study Closeout.● Ability to work in cross-functional team-oriented environments.● Understanding of ICH and the regulatory environment as it pertains to data management.● Experiences with Electronic Data Capture (EDC) processes along with Paper DM ● Ability to adapt to new technologies.● Experience with Central Lab Data Transfer Agreement (DTA). ● Strong project management skills with good oral and written communication skills.● Ability to communicate effectively with medical personnel.● Customer focus with good organizational, time management skills, and effective interpersonal skills ● Experience in creating Edit checks and Query Logics in the Data Validation Specification (DVS) documentand performing User Acceptance Testing (UAT) during the study setup phase. ● Worked extensively during the study conduct activities such as Discrepancy Management, Central Lab/Local Lab/Vendor Reconciliation, and SAE Reconciliation.● Experience in working with Protocol Deviations and CAPA.● Ability to lead and facilitate meetings, strong experience in attending Clinical Trial Meetings. (CTTs)● Ability to develop and deliver (technical) training.● Proven flexibility and adaptability.● Ability to work in a team or independently as required.