Experience

Clinical Biometrics Solutions Limited

• United Kingdom
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Business Development Manager

  • Jul 2021 - Present

  1. Designing and writing the protocol, taking the nature of the product into consideration (optimal trial design for the targeted population, calculation of sample size, etc.) 2. Selection of clinical sites, principal investigators, and accredited laboratories 3. Obtaining ethics committee approvals and performing authority notifications 4. Designing the data management platform to conduct the clinical trial 5. Preparation of patient recruitment plan and retention strategy 6. Preparation and distribution of clinical trial documentation 7. Investigational product labeling, use of depot, and distribution services 8. Clinical trial coordination, project management, and monitoring 9. Pharmacovigilance 10. Data management and statistical analysis with seamless integration of CDISC (SDTM) standard version 3.2 inbuilt EDC 11. Writing final report and/or publication of scientific articles 12. Project Management 13. Data Management 14. Statistical Analysis 15. Medical Writing 16. Remote data Monitoring 17. Regulatory Monitoring 18. Pharmacovigilance 19. Big Data Analytics for both healthcare and non-healthcare 20. Application Development such as (CTMS, EDC, ePRO and functional applications) Show less



IQVIA

• United States
• Hospitals and Health Care
• 700 & Above Employee

• Centralized Monitoring Lead

  • May 2016 - Jul 2020

  Activities performed included but were not limited to a) Risk Mitigation b) Resources allocation & updating c) Trainings d) Budget management e) Project timeline management f) e-TMF review g) Investigator Payments h) Vendor Management i) Access management j) Reviewed & Approved Monitoring Visit Reports k) Reviewed IEL (Issue Escalation log), protocol deviation logs as explained in the protocol on a regular frequency l) CTMS management, e-CRF query & SDV backlog management. Show less



IDS Infotech Limited

• India
• IT Services and IT Consulting
• 700 & Above Employee

• Senior Medical Analyst

  • Jun 2015 - May 2016

  Performed clinical data management & validation of medical information specializing in capturing medical information complying with HIPAA & regulatory requirements. Performed clinical data management & validation of medical information specializing in capturing medical information complying with HIPAA & regulatory requirements.



INVENTURUS KNOWLEDGE SOLUTIONS PRIVATE LIMITED

• 400 - 500 Employee

• Medical Data Analyst

  • Nov 2014 - Jun 2015

  Documenting clinical data, for subject visits, clinical entry, and query management for efficient patient care. Documenting clinical data, for subject visits, clinical entry, and query management for efficient patient care.



Impetus Translational Services

• Entrepreneurial Business

  • Jan 2013 - Oct 2014

  Started my own contractual consultancy conducted training, seminars for reputed Police Academies on indigenously designed practical programs as Disaster Management, Handling Medical Emergencies, Basic & Advanced Life Support Systems (BLS / ALS). Started my own contractual consultancy conducted training, seminars for reputed Police Academies on indigenously designed practical programs as Disaster Management, Handling Medical Emergencies, Basic & Advanced Life Support Systems (BLS / ALS).

• Corporate Technical Expert

  • Jul 2013 - Sep 2013

  Trained & mentored IDS staff on medical terminology, usage of medical dictionaries such as MedDRA, an entry in eCRF, medical coding. Trained & mentored IDS staff on medical terminology, usage of medical dictionaries such as MedDRA, an entry in eCRF, medical coding.



Cliniminds India

• Education Management

• Franchisee owner cum Centre-Head

  • Jun 2011 - Jan 2013

  Managed my own franchisee as center head for a clinical research training institution. Worked on planning & creating business models, training individuals to work in clinical research, clinical data management, pharmacovigilance, medical writing, SAS, & regulatory environment. Conducted seminars in colleges & universities. Managed my own franchisee as center head for a clinical research training institution. Worked on planning & creating business models, training individuals to work in clinical research, clinical data management, pharmacovigilance, medical writing, SAS, & regulatory environment. Conducted seminars in colleges & universities.



ADI Group

• India
• Real Estate
• 1 - 100 Employee

• Clinical Data Manager

  • Apr 2008 - May 2011

  Worked on the preparation of market research analysis, & competitive analysis for drug development for pharmaceutical companies requiring clinical study bench-marking for clinical research & regulatory requirements. Worked on the preparation of market research analysis, & competitive analysis for drug development for pharmaceutical companies requiring clinical study bench-marking for clinical research & regulatory requirements.