Nikita Gore

Experience in Clinical Data Management of Phase I to III in Oncology studies, knowledge and understanding of Veeva Vault and Octalsoft database.

Under

Supervision preparation and creation of eCRF specification, Edit Check Specification, CRF completion guidelines, Data Management Plan, PD Edit Checks, RTSM edit checks data entry with different users, Vendor Data Reconciliations, Therapeutic Expertise includes studies with indication like Hepatology, Gastroenterology, Oncology.

Clinical Data Coordinator - KlinEra Global Services

(2024-07)

Clinical Data Management

• Develop, under supervision data Validation Specifications and data management plan, CRF design
• Under supervision RTSM test script data entry UAT by using different user logins.
• Develop PreScreen UAT Test script using eCRF specifications and Protocol Deviation Test scripts.
• Participates in internal team meeting and distributing allocated work within team members.
• Develop, under supervision, CRF completion guidelines, User Acceptance Test Scripts of data entry for study database.
• Perform under supervision User Acceptance Testing for development study database.
• Perform under supervision data entry and QC of Edit check specification, develop Change Control request form.
• Participate with supervision in Vendor Data Management of SAE, RTSM, ECOA, SAMPLE Reconciliation test script preparation, UAT, data reconciliation, and query raising activities.
• Participate with supervision in Flag & Manual listing review using IRDP plan document as assigned.
• Participate with supervision in Query Details Review listing, Lab Normal Ranges query activity as per instructions.
• Prepare, under supervision, QC Load files, Reconciliation for QC (Lab Load) file and Source Data file as per instructions.
• Other data management duties and responsibilities as assigned.
• Experience in handling clinical data management tools such as Veeva Vault database and Octalsoft database.
• Assisted in onboarding and training of new team members

Masters of Science - Analytical Chemistry - Guru Nanak Vidyak College, GTB Nagar, Mumbai University (2021)

Bachelor in Science - Chemistry - V. K. K.

Menon

College of Bhandup, Mumbai University (2019)

H.S.C - Science - P. V. G.

Vidya Bhawan

College, Ghatkopar, Maharashtra State Board (2016)

S.S.C - S. S. M.

Pragtik Vidyalaya

School, Bhandup, Maharashtra State Board (2014)