Experience

COD Research Private Limited
• Business Development

  • Nov 2021 - Present


Oxter Research Pvt. Ltd.

• India
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Clinical Operation & Business development

  • Jun 2019 - Nov 2021

  1. Handling US and Europe market 2. Generating potential leads amongst generic pharma companies 3. Identification of leads – generic pharmaceuticals, marketing/manufacturing companies, companies for formulation development and BA/BE studies. 4. Drafting/managing the agreements and proposals in consultation with the technical team & finance to meet the client’s needs and objectives and carrying out business negotiation with clients. 5. Effectively managing different business models Contract R&D - Fee for Service, in/Out-licensing, Co-development, Commercial Supplies BA/BE Studies (Pilot / Pivotal studies) for different regulated markets 6. Managing key accounts and build strong business relationships with clients by championing the client’s needs. Working with clients to improve operational aspects. Coordinating with the technical team for the timely completion of the project. Taking regular updates on the progress of the project. 7. Working closely as a part of the Business Development team for all the supporting functions like sales forecasting, sales review meetings, monthly project review meetings and client meetings 8. Negotiating the deal to have a win-win business 9. Coordinating with the project management team for handling client queries. 10. Performing market research and portfolio management 11. Attending conferences or exhibitions, meeting new clients and understanding their needs in terms of product development or commercial manufacturing or other standalone services See less. Show less



pharmazone

• India
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Clinical Monitor

  • Aug 2016 - May 2019

  - Direct, lead, monitor and manage the Project Teams. Organize and facilitate effective meetings. Define clear and realistic goals, identify and delegate action items, follow-up/track action items to resolution, updates project plans & deliverables as required, identifies and ultimately resolve issues and facilitate rapid decision-making that will result in a timely, cost-effective and high quality execution of the assigned programs.- Report to Senior Management all exceptions to the project timelines. Provide strategies and practical solutions to the team and the management to resolve complex issues. Provide innovative, thorough practicable, business-driven solutions to a variety of difficult technical problems in BA-BE/clinical phase study monitoring.- Effectively plan, execute, manage and deliver on other projects at the site level. Provide leadership in program execution, resolution of issues, problem-solving, and decision-making.- Effective client communication with timely study updates, help to manage their timelines; guide them for ‘corrective actions’ to be taken by the site.- Communicate any observations, deviations to the protocol, safety alerts, quality issues, trends/patterns, risk factors, etc. that may affect the planned conduct of the trial to the clinical team and CRO / directly to site/ to the client for timely follow-up of actions and issue resolution.- To train newly joined Project Coordinators or Project Trainees with proper induction program, Classroom training and act as mentor/trainer to facilitate complete SOP/regulatory/GCP, etc. training- Giving strong efforts and complete involvement in SOP preparation & review of SOP of Pharmazone- With all this side by side, tracking of projects in time line via communication with clients.- Timelines Management and to ensure timely delivery of Project Reports to clients. Show less

• Project Coordinator

  • Aug 2016 - Jul 2017

  Responsibilities as Clinical Trial Monitor (GCP):- To ensure all personnel at study sites are appropriately informed and trained before the study starts in accordance with Protocol, Schedule Y, ICH-GCP Guidelines, and other applicable regulatory requirements and assurance of good site performance. This includes information and training on Protocol, AE/SAE reporting, case report forms (CRF), patient information sheets and informed consent process (ICF), storage and accountability of Investigational product, and requirements of Good Clinical Practice.Responsibilities as Medical writer:- Responsible for reviewing Protocols, case report forms (CRF), Clinical Study Reports (CSRs), Common Technical Documents (CTDs), Informed consent forms (ICFs), and Investigator Brochures for Bio Equivalence (BE) trials. Show less