Divya Gupta Email & Phone Number

India

Delhi

• Implement and manage clinical studies in all phases of development.• Review EC and regulatory dossiers and coordinate for approval.• Review key milestones planning, forecasting and tracking of all clinical studies.• Identify improvement efforts to enhance the productivity and consistency of study management activities throughout the clinical study process.• Ensure compliance to the quality policies and regulatory guidelines.• Resolve queries (both internal and external) related to current processes and regulatory guidelines.• Identify, escalate, resolve and document protocol and process deviations.• Maintain audit readiness at all time point.• Supervise clinical study teams with regards to the performance of core job tasks.• Reviewing of clinical trial documents like protocol, IB, ICF, CRF, Clinical study report, etc.• Track matrices to assure timely completion of clinical studies.• Meet with Clinical Investigators and their staff prior to study initiation to ensure all aspects of the study are understood by the investigator and staff, confirm the appropriateness of the IRB and ensure that all documentation required to initiate the study is complete.• Monitor study progress to assure compliance with protocol requirements, FDA regulations and Good Clinical Practice by conducting site visits as directed by the Sponsor.• Monitor and track patient enrollment and study progress.• Perform site audits to include source document review.• Ensure the track patient enrollment and study progress.• Identify, address, and resolve issues and problems as they might occur.• Assist the Sponsor/CRO in problem solving and provide consultation on monitoring and study related activities.

New Delhi Area, India

Delhi

Promotion of Ethical Clinical Trials in IndiaUndertake clinical research awareness and training activities Organization and Management of an Independent Ethics Committee

Delhi

Hyderabad Area, India

• Knowledge of Competitive Intelligence, Secondary research, Report writing along with a basic understanding of life science & pharmaceutical sector including drug discovery & development, clinical trials, pharmaceutical marketing, market sizing and market forecasting.• Endowed with good interpersonal skills with a strong teamwork focus & dedication to work and knowledge of various commonly used databases.• In depth research about pipeline drug’s description, mechanism of action, target and R&D activities.• Profiling and Authorization of pipeline pharmaceutical products in their early developmental phases including preclinical and clinical trials.• Research skills in validation of pipeline database.• Value Addition in the Database by Updating latest news, mergers, acquisitions, grants, etc.• Capturing the deals of companies done in reference to their pipeline pharmaceutical drug candidates.• Tracking down any new pipeline change and strategy modifications of Top Companies involving inactivation, discontinuation of a drug program, licensing, collaborations, Phase changes, trials etc.• Updating the product profiles in accordance to the financial filings of companies.• Tracking down Annual Reports, Half Yearly Reports, Quarterly Reports and Current Reports of top Pharma Players and updating the database asap.• Correction of the product profiles as per company statements, Clinical Trial results and third party sources involving Mechanism of Action, Target of drug Candidate, Indication, Therapeutic Class, ATC class, Molecule type, Technology etc.• Updating Clinical Trials from Various International CT registers. Adding new CT information and results.

Professional Certificate In Pharmacovigilance, Clinical Research

Master Of Technology (Mtech), Biotechnology

Bachelor Of Technology (B.Tech.), Biotechnology