Vijayendra Shenoy Padav
Senior Global Trial Manager
Copehagen
Summary
A versatile, result driven Project Management professional with key interest in Project cum People centric roles in Clinical Operations. What I bring to the table is diverse experience from Trial Management and Data Management in handling clinical trials, building processes, sound knowledge of clinical systems and developing relationships.
Overview
11
11
years of professional experience
4
4
years of post-secondary education
2
2
Certifications
Work History
Senior Global Trial Manager
Novo Nordisk A/S
Copenhagen
02.2023 - Current
- Leading and project managing local/regional trial team members for successful initiation, conduct and closure of assigned clinical trials.
- Leading and supporting local trial teams in timely preparation of required trial documents, contracts and necessary approvals.
- Ensure clear communication and report trial progress to relevant stakeholders and in relevant systems.
- Ensure appropriate trial oversight by monitoring compliance of trial sites/data to trial protocol and their adherence to GCP, local regulations, SOPs.
- Provide status on budget estimate and variations to Project Leads.
Global Trial Manager
Novo Nordisk A/S
Copenhagen
08.2021 - 01.2023
- Awarded and appreciated by management for timely completion of recruitment in a complex trial set-up.
- Refer 'Senior Global Trial Manager' description for overview on roles and responsibilities.
Clinical Trial Data Manager
Novo Nordisk A/S
Copenhagen
05.2018 - 08.2021
- Accountable for project management and end-to-end trial delivery of data and services from Data Management.
- Ensure clinical data to meet applicable regulatory requirements, quality, and data standards.
- Contribute to effective communication and information within the Trial Squad, with key stakeholders.
- Prepare/participate in audits and inspections.
Project Manager - DM Safety
Novo Nordisk Service Centre (India) Private Ltd
Bangalore
03.2016 - 05.2018
- Worked across Data Management, Safety, and Vendors to establish a standard process for Event Adjudication data collection in Novo Nordisk.
- Authored guidelines and reviewed SOPs to facilitate transition of tasks to task owners as defined by organization.
- Conduct trainings across the Data Management community.
Trial Data Programmer
Novo Nordisk Service Centre (India) Private Ltd
Bangalore
01.2017 - 05.2018
- Handling all trial execution related to the Data Management systems (CDMS, EDC, TMS) with regards to the set-up phase; and the integration of these systems to IWRS, Impact and Clinical Data Warehouse (CDW).
- Deliver data validation checks to Data Management for clean data during the conduct and closure of the trials.
- Resolve problems, develop processes to facilitate seamless data delivery to trial stakeholders.
- Handling critical accounts like data kill and mass changes.
Associate Trial Data Programmer
Novo Nordisk Service Centre (India) Private Ltd
Bangalore
05.2013 - 12.2016
- Create/Review of trial documents like Trial Specific Interface Requirement (TSIR), EDC-OC mapping, Lab/non-lab data specifications, Validation Plan and more.
- Perform trial tasks like database build, programming and testing of validation checks and data loads.
Training Associate
FACE - Focus Academy for Career Enhancement
Coimbatore
08.2012 - 05.2013
- Worked with central management to identify, plan, align, and address training needs of student community.
- Train students for placement interviews on Aptitude, Soft skills and Personality Development.
Education
Bachelor of Engineering - Biotechnology
NMAM Institute of Technology
Udupi, India 08.2008 - 06.2012
Skills
Project Management People Management Clinical Operations and Trial Management Clinical Data Management Clinical Data Standards and Systems Good Clinical Practice Training and Mentoring Easy Adaptability - Citizen of the World
Certification
Management Development Programme Training - Soft Skills for Interpersonal Effectiveness: Attitude and Skill Enhancement Lab
Work Availability
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Quote
Success comes to those who meditate on their dreams and work for it.
HH Srimad Samyameendra Theerta
Timeline
Senior Global Trial Manager
Novo Nordisk A/S
02.2023 - Current
Global Trial Manager
Novo Nordisk A/S
08.2021 - 01.2023
Certified Six Sigma Green Belt, Edurekha - License No BT4UNP6G
04-2019
Clinical Trial Data Manager
Novo Nordisk A/S
05.2018 - 08.2021
Trial Data Programmer
Novo Nordisk Service Centre (India) Private Ltd
01.2017 - 05.2018
Project Manager - DM Safety
Novo Nordisk Service Centre (India) Private Ltd
03.2016 - 05.2018
Management Development Programme Training - Soft Skills for Interpersonal Effectiveness: Attitude and Skill Enhancement Lab
06-2015
Associate Trial Data Programmer
Novo Nordisk Service Centre (India) Private Ltd
05.2013 - 12.2016
Training Associate
FACE - Focus Academy for Career Enhancement
08.2012 - 05.2013
Bachelor of Engineering - Biotechnology
NMAM Institute of Technology
08.2008 - 06.2012
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