Srinivas Siddappa

Experience

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  Macleods pharmaceuticals Ltd.

  Apr 2006 - Jan 2007

  Clinical Research Associate, Medical Services

  •New drug development, Managing clinical trials (monitoring).- Screening new molecules, preparing appraisal of them, promoting for further development •Planning protocol, Case record forms and Consent forms.- Preparation of protocol, CRF, center reports, pooled reports.•Data management, Regulatory dept. support, related to product leaflet, Export queries.- Preparing pack leaflets, solving DCGI related queries.•Patent search, Literature survey- Safety & efficacy data, clinical data, patents (US, EU, WIPO, Japan) •Drug controller activity - Filing of new products to DCGI.- Permission for CT, B.E, sending samples to CDTL- Manufacturing and marketing permission for drugs. Show less

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  Accenture

  Feb 2007 - Dec 2010

  •Assesses the quality of the clinical trial data that has gone through the CDM process from data entry to clean patient status by performing the CRF to database inspections (Complete CDM Checks) for randomly selected patients either on an ongoing basis or after the database is locked. These reviews are thorough and accurate.•Conversant with relevant CR&D SOPs, CDM SPIs, GCP and other applicable regulations.•Possess good working knowledge of protocol requirements and standard as well as project specific guidelines.•Understands the mechanism of the QE workflow process and is able to identify types of problems. Documents these in a clear and concise fashion and reports these to the project personnel for resolution.•Adjusts write-ups/ counts per resolution/ feedback and verifies and finalizes patient write-ups or seeks further clarification. Show less •Highly skilled in performing quality checks and documenting findings on different therapeutic areas like (Oncology, Clinpharm, Vaccines, Internal Medicine, Inflammation, Women’s Health, etc).•Acquaint with the protocols and guidelines before performing quality checks.•Submit findings to the respective TL/CDVX for review and finalization.•Input all details of quality checks in the respective trackers.•Perform the quality checks for the workload allocated to them within the given timeframe with good quality.•Identify trends of errors and suggest improvement areas for data validation. •Provides editing support to maintain skills whenever feasible.•Assist team leaders in resolving complex issues. Show less •Certified as Clinical Data Validation Associate and the position ensures the completeness and validity of the data in the clinical database.•Reviewing & processing clinical trial data to ensure the accuracy & consistency of clinical databases.•Analysing and resolving discrepancies identified by the system or through manual checks as per the data editing guidelines.•Applying validation rules, to check for correctness & meaningfulness of data inputted to the system.•Competently editing the database in compliance with departmental/project standards.•Utilizing current study documentation including protocols, Case Report Forms (CRFs), Data Validation specifications, etc.•Writing data clarification form and sending to the site for response. •Has been trained to perform the Quality document review and to capture the findings in a standard template.•Performed QDR process for more than 35 studies and these documents are auditable by FDA. Show less

  • Quality Evaluation Reviewer, Clinical Data Management

    Jun 2010 - Dec 2010

  • Quality Assessor, Clinical Data Management

    Oct 2007 - May 2010

  • Certified Data Validation Associate

    Feb 2007 - Sept 2007
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  JPS Health Network

  Jan 2011 - Mar 2014

  Willow Inpatient Clinical Analyst at JPS Health Network, Fortworth, TX

  •Work on deliverables as stated for a project / capability development•Ensure all deliverable are within accepted timelines and quality measures•Participate in domain training and conducted knowledge sharing sessions•Build skills and client reference ability through certifications•Manage and Work with the team to ensure diverse knowledge across projects is shared•Model build, customizations, review and documentation•Team Building, Assets building, & Capability Building activities•Active contribution in Validation and Re-engineering sessions for willow module•Aware of the entire process involved in third-party medication data vendor load – FDB Load•Aware of the entire process involved in handling the third-party dispensing med stations: Automated Dispensing Stations – PYXIS Med station•Application and Integrated testing cycles on NOVA release notes•Trained and independently worked on EPIC EMR Security and Access module and related tickets. Show less

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  Cleveland Clinic Abu Dhabi

  Apr 2014 - May 2015

  Willow Inpatient Clinical Analyst at Cleveland clinic Abu Dhabi

  •Manage and Work with the team to ensure diverse knowledge across projects is shared•Model build, configurations, customizations, review, documentation and Testing (system, content, UAT)•Application maintenance, enhancements and incident management and support.•Assisted on the entire process involved in third-party medication data vendor load – FDB Load•Worked on the entire process involved in handling the third-party dispensing med stations: Automated Dispensing Stations – PYXIS Med station, Phamogistics.•Aware of the entire process involved in PBM – Pharmacy Benefit Management. Show less

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  NYULMC

  Jul 2015 - Mar 2016

  Willow Inpatient Clinical Analyst at NYULMC

  •Manage technical support, Implementation, Optimization and Testing for Epic product and experienced with all phases of the Epic system implementation (plan, design, build, test, implement and support)•EPIC Implementation and Support coordinator for Willow Pharmacy as well as Beacon, Epiccare Ambulatory, Inpatient Orders and Clindoc Applications.•Responsible for design, configuration and on-going maintenance of the Willow Pharmacy and also responsible for handling Willow Pharmacy incident queue and coordinate with business owners for resolution•Create and maintain workflow charts, process documents, build manifest documents and end user guides•Work closely with onshore and offshore stakeholders in setting up the offshore model•Involved in project management activities which include preparation of Weekly Status Report, planning and implementation of the day to day activities of the team members, team utilization metrics etc•Managing the Team, Team Building, Assets building, & Capability Building activities•Manage and Work with the team to ensure diverse knowledge across projects is shared•Work on deliverable as stated for a project / capability development and ensure all deliverable are within accepted timelines and quality measures Show less

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  Mount Sinai Health System

  Apr 2016 - Sept 2016

  Willow Inpatient Clinical Analyst - Team Lead

  •Worked as an EPIC Implementation and Support Application coordinator for Willow Pharmacy as well as Epiccare Ambulatory, Inpatient Orders and Clindoc.•Responsible for design, configuration and on-going maintenance of the Willow Pharmacy and also responsible for handling Willow Pharmacy incident queue and coordinate with business owners for resolution•Involved in project management activities which include preparation of Weekly Status Report, planning and implementation of the day to day activities of the team members, team utilization metrics etc•Work on deliverable as stated for a project / capability development and ensure all deliverable are within accepted timelines and quality measures Show less

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  Cleveland Clinic

  Oct 2016 - Dec 2021

  Sr Application Analyst- Willow Ambulatory and Willow Inpatient at Cleveland Clinic Abu Dhabi

  • Malaffi Health Information Exchange (HIE) integration project- Real-time tracking for Medication Ordering project.- Near real time Dispense tracking Project.- Near real time Medication Administration project.• Epic / In-health integration for the Controlled medication unification (CMU) project.• Epic Point of sales project for Prescription dispensing• Home Delivery Pharmacy implementation project• Eye Clinic Pharmacy implementation project• Epic / My-chart patient portal – various enhancements improving the patient experience using the Willow Ambulatory services in collaboration with Portal team.• Pharmacy Business Manager (PBM)-Shafafiya integration project for improved end to end prescription authorization, claims submission and remittance advice reconciliation.• Sepsis predictive analysis modelling project – Assisted in configuring the Willow pharmacy application for various identified predictive score models for business.• End to end life cycle implementation and support for several Epic Go-lives and was part of several Epic Upgrades. • Assisting and supporting enhancement of application using Artificial Intelligence method of technologies. Show less

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  GAVS Technologies

  Feb 2022 - Feb 2023

  Consulting Manager Healthcare
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  Accenture

  Mar 2023 - now

  Associate Manager