Niraj Shah Email & Phone Number

Bengaluru, Ka, In

India

•Steering end to end project & delivery management functions for smooth execution of several oncology trials within a compound•Leading a team of 30 Data Managers and Data Team Leads for managing Oncology - Therapeutic Area Operations•Managing scope of work, budgets, forecasts, timeline, deliverables, milestones, quality, and risks in Data Management, Data Systems on responsible studies•Collaborating with the Clinical Data Management personnel for project timelines, delivery data and frequent project updates; sharing status/ dashboards with management & stakeholders to update them about project progress •Implementing service guidelines that serve as benchmark for excellent service delivery as per global standards & SLAs•Providing TA level inputs on monthly budgeting and invoicing of project hours to sponsor•Validating employee timesheet and ensuring the project hours are appropriately coded•Acting as a SPOC for conducting various study activities across start-up, maintenance and close-out phase•Attending study kick-off meetings and internal/sponsor audits for assigned studies•Maintaining nil interruptions in data, software flaws and minimal human error; taking corrective action as and when required•Reporting quality of data collection and site issues to the Data Manager; apprising on the status of each project•Ensuring that at the end of study, all data clarification forms are resolved, data is “cleaned”, data transfer is sent to the sponsor as per the agreed specifications and files are completed & archived appropriately•Organizing trainings for new joiners and conducting refresher trainings for the Data Management Team•Ensuring employee engagement, taking regular 1:1 feedback sessions, doing skill-gap analysis and evaluating the performance based on their quarterly study metrics•Addressing employee issues and resolving problems on HR matters.

Bengaluru Area, India

Pune Area, India

Functional manager to a team of Data managers.Single point of contact to the sponsor/Client for any study related issue or query.Testing the database and preparation of the DB design report. Preparation of the study documents like Trial validation plan, Test plan, Data handling decisionsResolving automated and manual discrepancies. Creating manual queries, DCFs. Updating DCFs in the database.

Mumbai Area, India

At TCS, worked as Clinical Data Manager, wherin my responsibilities included preparation of Edit check document, Testing the edit checks in oracle, making relevant documents, Discrepancy or query management, Medical coding, DCF creation - printing - update, manual review of patient data, Final and critical QC of database, address AE and SAE to client at proper interval and to resolve queries if any.In addition, I also had additional responsibilty looking after CRF design activities, reviews and helping out the team. It also involves handling the team in absence to CRF design Team lead and taking care of the issues and other activities.

Bachelor Of Pharmacy (B.Pharm.), Pharmacy

Activities and Societies: Indian Pharmaceutical Association Studies Pharmacy

Ssc, Standard X

Activities and Societies: Arranging yearly inter collegiate events. Discuss on social cause enagagements across colleges Pharmacist