Python, SAS, Unix, Power BI, MS Office (*Visio & Project)
Yogesh Goyal
Operations Manager
Bengaluru,KA
Summary
Respectful Clinical Manager with extensive knowledge of health care administration and clinical philosophy. Familiar with fiscal management systems and human resource management. Talented at maintaining and developing effective relationships with staff, patients and senior management. Excellent supervisory skills and performance working under pressure.
Overview
12
12
years of professional experience
5
5
years of post-secondary education
1
1
Certification
2
2
Languages
Work History
Operations Manager
Accenture Pvt. Ltd.
Banaglore, Karnataka
03.2020 - Current
- Develop and implement operational support model and training delivery plan to setup new projects, teams and support the evolving needs for an ongoing business process
- Owns the governance strategy, roadmap, execution, and monitoring of the business process, people & technology
- Effectively managing and engaging key stakeholders as per governance strategy to ensure business needs and requirements are met, prioritized and communicated.
- Performs process impact assessments as needed to determine breadth and risks involved with proposed change initiatives
- Partners with IT to set and drive a clear roadmap for the business capability that includes proper demand management, release planning and release management of technology system(s)
- Partners with R&D functions, internal and external partners including vendors on strategy, development, implementation, and oversight of enhancement to current business capability
- Accountable for system/technology performance, platform, integrations, project budget, stakeholder communications/change management, resolution/mitigation of issues and risks.
- Embraces a culture of quality, compliance and data integrity to promote a state of inspection readiness for the business capability
- Planned and resourced personnel and logistics for operations component exercises resulting in highly trained personnel ready to act quickly in critical roles
- Worked in matrix management environment with oversight of process, people & technology
Cluster Head (eTMF & CTMS)
Accenture Pvt. Ltd.
Banaglore, Karnataka
01.2018 - 04.2020
- Involved in designing & implementation of trial master file at client and study level
- Established an optimized process for CSR appendices generation and CTD submisions
- Application upgrade and test planning for applications like Veeva Vault, CTMS & ECLIPSE
- Supported EMA & FDA audit for 2 oncology program
- Exceeded goals through effective task prioritization and great work ethic
- Created plans and communicated deadlines to complete projects on time.
- Participated in team-building activities to enhance working relationships
- Build Operational Capabilities for respective processes
- Coach Team leads and team members - Providing formal and informal training
- Build Right Metrics and required measurement system to collect data for the identified metrics
Team Lead (Clinical Programming)
Accenture Pvt. Ltd.
Bangalore, Karnataka
01.2016 - 01.2018
- Monitor individual contributors who are working on statistical programming projects
- Translate study protocol and Statistical Analysis Plan into algorithms and specifications to achieve analysis and CDISC standards
- Create and/or validate all safety and efficacy study output requirements (e.g. SDTM, ADaM, TLFs, etc.) consistent with data definitions and specifications and relevant study documentation (e.g. protocol, SAP, aCRFs, etc.)
- Provide accurate and timely responses to routine requests from clients and with limited supervision responses to non-routine requests from clients
- Ensure accuracy of database and develop database checks for routine situations and with limited supervision develop checks for non-routine situations
- Manage and maintain programming specifications for SDTM, ADaM, analysis dataset & analysis outputs
- Additional general team lead duties
Clinical SAS Programmer
Accenture Pvt. Ltd.
Banaglore, Karnataka
03.2012 - 03.2016
- Build SAS datasets from clinical database
- Develop SAS macros, templates and utilities for data cleaning and reporting
- Implement analyses specified in the protocol or the Statistical Analysis Plan (SAP) while working with the project statistician.
- Ensure CRF meets the guidelines of the protocol and check for consistency and adequacy.
- Write SAS programs to generate tables, listings, and figures and analysis datasets.
- Review CRF annotations and data specifications.
- Identify and edit checks per the data validation plan or data management plan.
- Validate the programmed analysis datasets, tables, listing and figures.
- Perform analyses defined in the statistical analysis.
- Utilize SAS programming skills within protocol team and perform all programming required for clinical trial analysis and reporting.
Clinical Data Managment
Accenture Pvt. Ltd.
Banaglore, Karnataka
06.2010 - 04.2012
- Work with complex computerized records systems and maintain security and integrity
- Collect data from clinical trials
- Sort information and then ensure it's screened, grouped, summarized, transcribed, coded
- Manage clinical trials through review, computerization, cleaning and auditing of clinical data and databases in compliance with standard operating procedures, client guidelines and regulatory agency guidelines
- Validate clinical trial data to ensure consistency, integrity and accuracy based on project specific guidelines
- Generate data retrievals and summaries
- Query data inconsistencies and revise case report forms in compliance with standard operating procedures
- Review case report forms for completeness and consistency
- Implement strategy for data cleaning and the design and programming of clinical databases
- Review and approve design, data review ground rules and database design according to Standard Operating procedures and protocol
Education
MBA - Executive General Management
IIMB
Bangalore 07.2020 - 11.2021
Post Graduation Diploma - Clinical Research & Managment
Clinical Research Education & Managment Academy
Banglaore 08.2008 - 06.2009
Bachelor of Science - Biotechnology
Dayanand Sagar Institution
Bangalore 08.2005 - 06.2008
Skills
Project development and life cycle
Software
Certification
PMP
Timeline
MBA - Executive General Management
IIMB
07.2020 - 11.2021
PMP
07-2020
Operations Manager
Accenture Pvt. Ltd.
03.2020 - Current
Cluster Head (eTMF & CTMS)
Accenture Pvt. Ltd.
01.2018 - 04.2020
Team Lead (Clinical Programming)
Accenture Pvt. Ltd.
01.2016 - 01.2018
Clinical SAS Programmer
Accenture Pvt. Ltd.
03.2012 - 03.2016
Clinical Data Managment
Accenture Pvt. Ltd.
06.2010 - 04.2012
Post Graduation Diploma - Clinical Research & Managment
Clinical Research Education & Managment Academy
08.2008 - 06.2009
Bachelor of Science - Biotechnology
Dayanand Sagar Institution
08.2005 - 06.2008
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