Satish Kumar
Hyderabad
Summary
Expert in Clinical Operations and Project Management with a strong background in Site Management and Drug Development. Proven track record in leading global clinical operations as Team Lead for Central Monitoring at PRA Health Sciences, ensuring timely project deliverables with high quality. Currently managing over 100 clinical studies at eCentric Solutions, overseeing project management activities and resource training. Committed to advancing innovative treatment options and fostering team development to achieve organizational goals.
Overview
19
19
years of professional experience
1
1
Certification
Work History
Associate Director - GPMO
Novartis
Hyderabad
04.2023 - Current
- Developed and implemented process enhancements to improve operational efficiency.
- Collaborated with external partners to foster innovation and expand capabilities.
- Maintained positive relationships with stakeholders by responding promptly to inquiries, requests and complaints.
- Monitored budgeting, forecasting, planning and reporting activities of the department.
- Participated actively in decision making processes at a high level within the organization.
- Identified opportunities for improvement in processes, procedures, systems and services.
- Participated in staff meetings, working groups or task forces to implement strategic initiatives.
- Oversaw day-to-day operations of the organization including personnel management, program development and implementation.
- Created effective communication channels between different departments in order to facilitate collaboration.
- Implemented innovative solutions for difficult problems encountered by the department.
GPM Horizon Planner
Novartis
Hyderabad
06.2019 - 03.2023
- Analyzed data to identify trends and inform decision-making processes.
- Managed budgets and tracked expenses for various initiatives.
- Created detailed reports to communicate project status and updates clearly.
- Identified potential problems and created solutions to mitigate risks associated with projects.
Project Manager- Professional Services
eCentric Solutions Pvt. Ltd.
Hyderabad
04.2016 - 05.2019
- Ensured timely delivery of Medidata products and services within budget and quality standards.
- Led cross-functional teams to ensure project alignment and timely delivery.
- Served as primary client contact, managing relationships and expectations throughout the study.
- Regularly monitored project timelines, communicating updates to Senior Management and clients.
- Performed financial management for project budgets, including execution of Statements of Work and Change Orders.
- Facilitated regular communication with internal and external teams regarding study status and deviations.
- Identified and mitigated project risks by gathering stakeholder input and maintaining documentation.
- Delegated tasks effectively to maximize team productivity and engagement in project activities.
- Conducted training sessions for clients to enhance understanding of project functionalities.
Team Lead- Risk Based/Central Monitoring
PRA Health Sciences
12.2015 - 04.2016
- Managing a team of Central / Remote CRAs for their day to day activities in the assigned projects
- Providing direct supervision, support, training and mentoring to the Central CRAs (CRA I, II or Sr. CRAs) for meeting the project deliverables
- Reviewing the Observation Reports and queries before they are posted in iPortal and eCRF respectively
- Authorship of Monitoring Plan, input into eCRF completion guidelines, eCRF database and Data Handling/ Review Plan, Process development etc.
- Partnering with Clinical team and Data Management (DM) throughout study life cycle ensuring on time smooth DBLs with high quality data
- Collaboration with Clinical Study Manager/ study teams to resolve site issues and ensure the quality and integrity of site practices related to the proper conduct of the protocol and adherence to applicable regulations.
- Provided services to Novartis Healthcare Pvt. Ltd.
Global Lead CRA/ Senior Central CRA
PRA Health Sciences
01.2014 - 12.2015
- Managing a team of Central / Remote CRAs for their day to day activities in the assigned projects
- Providing direct supervision, support, training and mentoring to the Central CRAs (CRA I, II or Sr. CRAs) for meeting the project deliverables
- Reviewing the Observation Reports and queries before they are posted to iPortal and eCRF respectively
- Authorship of Monitoring Plan, input into eCRF completion guidelines, eCRF database and Data Handling/ Review Plan, Process development etc.
- Partnering with Clinical team and Data Management (DM) throughout study life cycle ensuring on time smooth DBLs with high quality data
- Centralized Clinical Data Analysis and providing remote support to field monitors for monitoring visits and site management for a variety of protocols, sites and therapeutic areas.
- Collaboration with Clinical Study Manager/ study teams to resolve site issues and ensure the quality and integrity of site practices related to the proper conduct of the protocol and adherence to applicable regulations.
- Coordinating with the FMs to resolve the issues in compliance with Good Clinical Practice (GCP), local regulatory requirements, and protocol.
- Tracking the progress of assigned studies for regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission.
- Analysis of the clinical data and generating the queries (related to safety, efficacy, endpoints and other protocol related discrepancies) in eCRF and providing the resolution to the queries/ discrepancies.
- Escalation of quality issues to Site Monitor, Clinical Study Manager (CSM), and/or line manager.
- Tracking the status of completion of different Clinical Systems for site visits, project milestones and data review.
- Participate in routine study progress meetings, face to face or via teleconference.
- Adhering with corporate internal polices and requirements, including submission of timesheets and expense reports in a timely manner.
- Knowledge of applicable SOPs, guidelines and study procedures.
- Assisting with the development of study manuals, annotated CRFs, monitoring conventions, tracking forms, site study tools, and other study materials.
- Developing and implementing innovative approaches for and participating in site recruitment, selection and initiation activities.
- Assisting with investigator meeting activities including organization, preparation and attendance.
- Conducting site management activities, including but not limited to site qualification visits, site initiation visits, site training, site interim monitoring visits, and site close out visits.
- Performing co-monitoring visits and performance assessment visits, when properly trained and delegated by Clinical Study Manager.
- Provided services to Novartis Healthcare Pvt. Ltd.
Clinical Research Associate 2
Quintiles Research India Pvt. Ltd.
04.2013 - 12.2013
- Perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice
- Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas
- Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues
- Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues to Clinical Team Lead (CTL) and/or line manager
- Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrolment, case report form (CRF) completion and submission, and data query generation and resolution
- Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports and other required study documentation
- Providing assistance to less experienced clinical staff.
Clinical Research Associate 1
Quintiles Research India Pvt. Ltd.
05.2011 - 03.2013
- Perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice
- Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas
- Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues
- Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues to Clinical Team Lead (CTL) and/or line manager
- Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrolment, case report form (CRF) completion and submission, and data query generation and resolution
- Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports and other required study documentation
- Providing assistance to less experienced clinical staff.
Assistant Manager- Site Operations
Excel Life Sciences Pvt. Ltd.
04.2009 - 05.2011
- Managing a team of more than 15 CRCs for their day to day activities (e.g. Patient enrolment, screening, randomization etc.)
- Managing the project for achieving the study milestones. Communication with sponsors for the study updates.
- Providing weekly communication/ updates of the project deliverable/ timelines to Country Head- Operations
- Protocol specific trainings to Principal Investigators and new study team members (Co-Is, CRCs/ trainee CRCs)
- Performing Internal Monitoring/Supervisory visits to the sites involved in the study
- Tracking study documentations and clinical supplies to the sites
- Participate in project specific trainings and project team meetings, as required
- Active involvement in Safety/ risk management activities (AE/ SAEs reporting etc.)
- Compilation and analysis of feasibility data and sharing it with clients
- Providing feedbacks and identifying the areas of improvement for resources.
- Arranging trainings for the resources- need basis/ regular
Clinical Research Coordinator (CRC)
Excel Life Sciences Pvt. Ltd.
02.2008 - 03.2009
- Assisting study managers for startup activities & site initiations.
- Working with study Monitors in completion of training of team at site regarding GCP, Protocol, Safety Reporting, maintenance of essential documents & regulatory documents such as ethics Committee submission and other regulatory requirements
- Coordinating with Ethics Committee for document submission, approval and queries
- On-Site Coordination of the overall conduct of the study to ensure compliance with study management, protocol, GCP & other requirements at all assigned sites
- Serving as a liaison with site / project managers/ sponsor
- Assisting the PI/ Co-I in the process of administering the informed consent to potential patients and discussing in detail the relevant information with the patients
- Scheduling subject visits as per the protocol to ensure maximal subject compliance & retention
- Follow up with the site team/ CRCs for timely completion of the Source Documentation and ensuring that all the relevant information required in the Case Record Forms are present in the source document
- Completing the Case Record Forms within the timelines and with minimal errors.
Project Assistant
Ranbaxy Research Laboratories
05.2007 - 12.2007
- Pre-clinical research activities.
- Worked on Single Cell Gel Electrophoresis (Comet Assay) on Sperm Cells of Albino mice treated with Cyclophosphamide.
Education
PGDBA - Operations Management
Symbiosis
Pune05.2014
M.Sc - Toxicology
Jamia Hamdard
New Delhi07.2007
B.Sc - Biology
Purvanchal University
Jaunpur05.2002
Skills
- EDC platforms: Medidata Rave, Impact, OCRDC, InFORMant
- Process improvement
- Budget management
- Data analysis
- Financial forecasting
- Cross-functional collaboration
- Effective communication
- Onboarding and training
- Project management
- Coaching and mentoring
- MS Office applications: Word, Excel, PowerPoint
- Clinical data mining tools
- Clinical trial management systems (CTMS)
- InFosario expertise
- Process optimization
- Data monitoring
Accomplishments
- ECentric Solutions/Medidata, appreciation certificates from Medidata for best performing offshore PM for two consecutive years (2016 and 2017). First PM from the offshore team to come into the spotlight.
- PRA Health Sciences, six appreciation awards for quality work.
- Quintiles Research India Pvt. Ltd., twelve WWD (Worth Work Doing) awards. It includes two WWD awards for achieving the monitoring visit target of over 150% with 100% report compliance.
- Excel Life Sciences, "Star Employee of the Quarter" award for the third quarter of 2008 for outstanding on-job performance. Nominated for the prestigious "Best CRC of the Year, 2009," an award sponsored by the Indian Society of Clinical Research (ISCR). Awarded as the best performing CRC for a T1DM study. Awarded a cash prize by the sponsor for being the highest enroller in the ophthalmology study.
Telephone
+91-8886588218
Personal Information
Date of Birth: 01/01/82
Publications
- Kalra S, Kalra B, Kumar S, Sharma A. Managing insulin resistance: role of liraglutide. Clinical Pharmacology: Advances and Applications 2010; 2: 131-134.
- Kalra S, Agrawal N, Kumar S, Sharma A. Testosterone replacement in male hypogonadism. Clinical Pharmacology: Advances and Applications 2010; 2: 149-153.
- Kalra S, Kalra B, Unnikrishnan AG, Agrawal N, Kumar S. Optimizing weight control in diabetes: antidiabetic drug selection. Diabetes, Metabolic Syndrome and Obesity: Targets and Therapy 2010; 3: 297-299.
- Kalra S, Kumar S, Kalra B, Unnikrishnan A, Agrawal N, Sahay R. Patient-provider interaction in diabetes: Minimizing the discomfort of change:. The Internet Journal of Family Practice. 2010 Volume 8 Number 2.
- Kalra S, Kumar S, Kalra B, Agrawal N, Sharma A, Prusty V. Knowledge, attitude and practice of type 1 diabetes patients regarding complementary and alternative medicine (CAM). Endocrine Abstracts 2010; 22: P280.
- Kalra S, Kalra B, Kumar S. The IMPERIAL Study: physicians' perceptions regarding intensification of insulin therapy. Endocrine Abstracts 2010; 22: P298.
Disclaimer
I do hereby declare that the above given statements are true and correct to the best of my knowledge.
Training And Workshops
- Training on ICH-GCP, CTMS, OC-RDC, InFORM, Medidata RAVE, Oracle Clinical, S Clinica (IVRS), JReview, ClinAdmin.
- Certificate course on Intellectual Property Rights from WIPO (World Intellectual Property Rights Organization) in 2008.
- Online Clinical Research training course, sponsored by National Institute of Health (NIH), U.S. Dept. of Health & Human Services.
- Trained on Drug Development, ICH GCP, Regulatory requirements in India, Site management logistics & protocol specifics at Excel Life Sciences.
Area Of Expertise
- Risk-based/central monitoring, process development
- Strategic initiatives and process improvements
- Data quality, reporting, business communication, and support
- People, project management, trainings
- Clinical site monitoring, SIV, SMV, and SCOV
- Client relationship, contract, and budget management
Languages
English
Proficient (C2)
C2
Hindi
Native
Native
Certification
Train the Trainer - Copilot (Microsoft)
Timeline
Associate Director - GPMO
Novartis
04.2023 - Current
GPM Horizon Planner
Novartis
06.2019 - 03.2023
Project Manager- Professional Services
eCentric Solutions Pvt. Ltd.
04.2016 - 05.2019
Team Lead- Risk Based/Central Monitoring
PRA Health Sciences
12.2015 - 04.2016
Global Lead CRA/ Senior Central CRA
PRA Health Sciences
01.2014 - 12.2015
Clinical Research Associate 2
Quintiles Research India Pvt. Ltd.
04.2013 - 12.2013
Clinical Research Associate 1
Quintiles Research India Pvt. Ltd.
05.2011 - 03.2013
Assistant Manager- Site Operations
Excel Life Sciences Pvt. Ltd.
04.2009 - 05.2011
Clinical Research Coordinator (CRC)
Excel Life Sciences Pvt. Ltd.
02.2008 - 03.2009
Project Assistant
Ranbaxy Research Laboratories
05.2007 - 12.2007
PGDBA - Operations Management
Symbiosis
M.Sc - Toxicology
Jamia Hamdard
B.Sc - Biology
Purvanchal University