Build your professional network on facebook via our app Go to app
Kusuma Vytla Clinical Research Manager, Novo Nordisk
 
Kusuma Vytla's Profile
Kusuma Vytla
Clinical Research Manager, Novo Nordisk
Novo Nordisk
confidential
confidential
Bangalore, India
Toostep 
Professional summary
Kusuma Vytla's Experience
Current :

Clinical Research Manager, Novo Nordisk
Pharmaceuticals
India, Bangalore

Working from 2009

Brief summary :

  • Currently with Novo Nordisk India Pvt Ltd, Bangalore as Clinical Research Manager responsible for 4 multinational research projects & managing a team of 2 CRAs

Previous :

Clinical Research Manager, Novo Nordisk India Pvt Ltd
Bangalore

Worked from 2009 to 2012

Brief summary :

Currently with Novo Nordisk India Pvt Ltd since August 2009, Bangalore as Clinical Research Manager responsible for 3 multinational research projects and managing a team of 2 CRAs Current Job Profile: Key areas of responsibility: Ensure the smooth conduct of all clinical trials sponsored by NNIPL in accordance with Good Clinical Research Practice (GCP) guidelines by NN A/s and local regulatory requirements. Planning, Forecasting and execution of assigned project Selection of appropriate investigators for specific clinical trials Assist the clinical operations director and regulatory manager in compiling documentation for submission to regulatory authorities for the purpose of clinical trials/ marketing approvals. Preparation of country and site recruitment strategy with the help of monitors Preparation of clinical trial budgets for the clincost system and external clinical trial costs To prepare Site specific Budgets and make timely payments to investigators. Keeping track of recruitment of subjects and monitoring visit plan Be alert while monitoring of clinical trials in order to ensure that data collected are accurate and verifiable Safety reports submissions to EC, HA, and IPS as per company SOP and local requirement Co ordinate with Local Depot to maintain inventory of trial products and ancillary supplies Review of clinical trial shipment documents like CTSR, temperature record graphs. Periodic update on recruitment, SAE, site specific issues, and trial products issues in monthly meeting Timely IMPACT update Regular co-monitoring with CRAs to check on compliance with protocol, Novo Nordisk SOP, ICH GCP and local regulations To expedite the trial in a swift and efficient manner with as few queries as possible Archiving of all trial related documents at the investigator site as well as at Novo Nordisk India Pvt Ltd as necessary Ensure that the rights and well being of all patients and investigators who are part of Novo Nordisk clinical trials are protected. Ensure smooth initiation, conduct and conclusion of all clinical trials as per the protocol and in accordance with Novo Nordisk SOPs and the regulatory requirements People Training of new colleagues in the Clinical Research Department. Assist the Clinical Operations Director in complying with the Novo Nordisk Way of Management and Novo Nordisk India Pvt Ltd quality system. Document the review and improvements in critical business processes from time to time Training and development of team members Regular site staff training on protocol, study related procedures, local SOPs and local regulations Other Constantly network among academicians and academic institutions to identify good centres for clinical trials To work with the peers in the company to ensure that customer focus continues to remain our prime objective. Assist Quality and Training Manager in implementation of quality systems within the organisation Preparation of contracts and cost negotiations with external vendors like, translators, suppliers of study related equipments etc. Previous work experience is as follows:

Previous :

Clinical Research Manager, Novo Nordisk

Worked from 2009 to 2012

Brief summary :

biography Ms. Kusuma Vytla, is working with Novo Nordisk since August 2009 as Clinical Research Manager. She has total of more than 8 years of Clinical Research experience. She had worked in different therapeutic indications like Diabetes, Gastroenterology, Systemic Lupus Erythematosus, Ophthalmology, Neurology and Cardiology. She is currently working as Regional CRM on 3 global phase III trials and her responsibility involves people management, project management and coordination with the sponsor, global study team, local sponsor affiliate and local study team. She is also responsible for the study progress, implementation of strategies and to resolve issues in consultation with project leader. She is also working on a global phase III Hemophilia study since 1 year and her responsibility involves site co-monitoring and management activities. She is well versed with the health questionnaires and various diagnostic tools such as BILAG and SELENA SLEDAI used in this study. She started her career in Clinical Research as a study coordinator in a Medical Institution and worked there on various global trials for a period of 1.5 years. After that she joined a multinational pharmaceutical company as Clinical Trial Assistant and learned various aspects of study logistics, study documentation and and data management. She also worked in reputed CROs for almost 1.5 years and gained extensive monitoring experience Since she has worked at site, in a pharmaceutical company as well as at CROs; this has helped her to better understand the working and perspective of all these players in clinical research industry. She has completed her graduation (B. Sc), from Bangalore University and an MBA from Manipal University. Languages English Hindi Kannada

Previous :

Clinical Research Manager, Novo Nordisk
Pharmaceuticals
India
Previous :

Clinical Research Associate/Scientist, Kendle International
Pharmaceuticals
India, Gurgaon

Worked from 2007 to 2009

Previous :

Senior Clinical Research Associate, Kendle India Pvt Ltd
Gurgaon

Worked from 2007 to 2009

Brief summary :

Senior Clinical Research Associate with Kendle India Pvt Ltd, Gurgaon from May 2007 to July 2009. Job Profile: Responsible for project start up, trial initiation, monitoring and close out activities while adhering to all applicable regulatory and Standard Operating Procedures (SOPs) and Project Specific Operating Procedures (PSOPs). To Develop and implement innovative approaches for site selection, and pre-study activities to identify and evaluate potential investigators. To develop and train new sites and investigators for conducting global clinical research studies as per the local and international regulatory requirement. Provide status updates of pre-study and initiation activities and manage and track investigator grants with study sites Develop patient enrollment strategies with the project team and study sites. Complete in-house monitoring activities as appropriate, such as updating in-house site files, and completing visit reports. Complete project activities associated with monitoring functions of Phase I-IV clinical research studies while developing an understanding of the drug development process, Good Clinical Practices, and relevant regulations. Provide clinical and technical support for CRA I and administrative staff. Identifies problems that interfere with study progress, implements strategies to resolve issues in consultation with Project Leader. Mentor study specific monitoring team and conduct Co-Monitoring/Training visits. Participates in the development of Informed Consent Forms and Case Report Forms. Responsible for development of study specific monitoring plan, annotated Case Report Forms, monitoring conventions tracking forms and other study related documents.

Previous :

Clinical Research Associate/Scientist, Jubilant Clinsys
Pharmaceuticals
India, Gurgaon

Worked from 2006 to 2007

Previous :

Clinical Research Associate, Jubilant Clinsys Ltd
Noida

Worked from 2006 to 2007

Brief summary :

Clinical Research Associate - Jubilant Clinsys Ltd, Noida from June 2006 to May 2007. Job profile: Responsible for project start up, trial initiation, monitoring and close out activities as per applicable local and international regulatory bodies. To train sites and investigators on ICH-GCP guidelines and ensure the same in adhered to. To ensure that logistics are planned for studies prior to initiation of trial and Identify and select and manage local vendors required for the study To perform site initiation, monitoring and close out of sites. To ensure clinical plan timelines and quality is maintained and also ensure inspection readiness at site level.

Previous :

Clinical Research Associate, - Pharm-Olam International ,
Bangalore

Worked from 2006 to 2006

Brief summary :

Clinical Research Associate - Pharm-Olam International, Bangalore from Feb 2006 to May 2006. Job profile: Conducted feasibilities in COPD, Oncology, Gastroenterology, Ophthalmology, Dermatology and Neurology studies. To conduct study site evaluations for Oncology, Gastroenterology and COPD studies. To maintain central site files and forward documents in timely manner to Sponsor.

Previous :

Clinical Trial Assisstant, AstraZeneca
Pharmaceuticals
India, Bangalore

Worked from 2005 to 2006

Previous :

Clinical Trial Assistant, AstraZeneca Pharma India Ltd
Bangalore

Worked from 2005 to 2006

Brief summary :

Clinical Trial Assistant - AstraZeneca Pharma India Ltd, Bangalore from Jan 2005 to Jan 2006. Job profile: To coordinate payments to study sites as well as payments to service providers in coordination with Finance Department. Prompt delivery of study drugs to study sites and proper documentation of study drug handling. To create and maintain central files to facilitate easy retrieval. To create site files and prepare initiation packets. Maintain an inventory of study supplies and dispatch supplies to sites. Online Study Data Management. To serve as a communication link between study centers and clinical research staff.

Previous :

Clinical Trial Coordinator, M S Ramaiah Hospital & Research Center
Hospitals
India, Bangalore

Worked from 2003 to 2005

Previous :

Hospital ,
Bangalore

Worked from 2003 to 2005

Brief summary :

Study Co-ordinator - M S Ramaiah Medical College and Hospital, Bangalore from Jun 2003 to Jan 2005. Job profile: Was involved mainly in Phase III and Phase - IV studies in Diabetes Mellitus, Dislipidemia, Cholesterol Lowering, Diabetic Neuropathy and Cardiovascular studies. Was involved in these studies from start up phase to completion phase. Target number of patients were reached within the enrollment period of 3 months in Dislipidemia and Cholesterol Lowering studies. To process patient visits as per the protocol. To maintain and dispense study drug to patients. To coordinate with the Institutional EC for the approval of study documents, quarter and annual study updates. To maintain inventory of CT material. To complete and forward CRFs to Data Management. To resolve and forward Data Query Forms to Data Management. To ensure study is conducted as per protocol and site is audit ready. Professional awards: Novo Nordisk Recognition for completing country recruitment in a record time of 12 days Recognized for zero percent data management queries for Diabetic Neuropathy study during tenure at M S Ramaiah Medical College and Hospital, Bangalore. Recognized for no findings during Sponsor audit in the Insulin Study in Type II Diabates Mellitus patients during tenure at M S Ramaiah Medical College and Hospital, Bangalore. LinkedIn Profile: HYPERLINK http://in.linkedin.com/pub/kusuma-vytla/18/406/a62 http://in.linkedin.com/pub/kusuma-vytla/18/406/a62 therapeutic areas of research experience Cardiovascular Cardiovascular - Type 2 Diabetes Mellitus CNS Neurology CNS Neurology - Urinary Incontinence Dermatology Dermatology - Melanoma Cancer Endocrinology Endocrinology - Dyslipidemia Endocrinology - Diabetic Neuropathy Endocrinology - Diabetes Endocrinology - Cholesterol-Lowering Endocrinology - Diabetic Macular Edema Endocrinology - Type 2 Diabetes Mellitus Gastroenterology Gastroenterology - Diverticulitis Immunology Immunology - Systemic Lupus Erythematosus Infectious Diseases Infectious Diseases - Chronic Obstructive Pulmonary Disease Ophthalmology Ophthalmology - Macular Degeneration

Kusuma Vytla's Education

Sikkim Manipal University
MBA/PGDM
India
From 2007 to 2010
Brief summary :

MBA in HR and Marketing

Bangalore University
B.Sc
India
From 1996 to 1999
Brief summary :

Bachelor's Degree in Science

 
 
Featured Career Adviser
International Executive Search
International Executive Search
 
 
 
Kusuma's communities
Healthcare & Life Sciences Professionals
11215 members, 39 jobs, 258 articles, 148 questions, 382 debates, 166 idea contests.
 
 
Related Topics
Solutions to implement into Business Performance Workflow Management into my...
1 insight , 1 question  
Skills required Strategies dveloped
1 insight , 1 debates , 1 idea contests , 2 question  
Examining a effective coaching and development strategies which will provide...
1 trends , 6 insight , 7 debates , 5 idea contests , 2 question  
  • Popular Knowledge
  •  
  •  
  • Popular Jobs
  •