Experience

Jodas Expoim Pvt. Ltd.

• India
• Pharmaceutical Manufacturing
• 300 - 400 Employee

• Clinical Trial Manager

  • May 2023 - Present

  SOPs writing and preparing (Clinical development and Clinical operations). Develop trials forms and tracking tools. · Managing trials budget. · Resolving protocol deviation issues. Review essential trials documents and provide science liaison support. · Prepare reports on clinical trial progress and evaluating critical points on projects lifetime. · Prepare visualization and plans on trials timelines (implementing Gantt chart and tasks management software). · Negotiation with vendors and supporting the creation of clinical trial proposals. · Support the general running of clinical trials and help overcome any potential issues. Show less



Syneos Health

• United States
• Biotechnology Research
• 700 & Above Employee

• Clinical Research Associate

  • Oct 2017 - May 2022

  During work period in the CRO as a site monitor was involved in 20+ clinical projects (phase II-III). Theraputic area experience included Oncology/Immunooncolgy, Psychiatry and Rheumatology. As CRA I performed site qualification, site initiation, regular monitoring, site management activities and close-out visits (performed on-site or remotely), was involved in SDV locks and snapshots. Implemented professional judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately escalated serious issues to the project team and develops action plans. Maintained a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes. Also, my job responsibilities was to verify the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. perform investigational product (IP) inventory, reconciliation and reviews storage and security. I applied knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned. Routinely reviewed the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (eTMF). Prepared confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan. Supported subject/patient recruitment, retention and awareness strategies. Entered data into tracking systems as required to track all observations (CTMS — Tesla by SalesForce, other internal sponsor's clinical systems), ongoing status and assigned action items to resolution. Worked in related trial systems (IxRS, CRF's). Show less



synergy research group

• Санкт-Петербург, Санкт-Петербург, Россия

• Clinical Research Associate

  • Aug 2015 - May 2017

  Customize paper data collection forms, and case report forms (CRFs). · Perform contacts with the ethics committee (local and central). · Manage regulatory applications and approvals that oversee the research and marketing of new and existing drugs. · Perform on-site visits for source data/document verification (SDV). · Prepare visit reports and issue escalation after monitoring activities. · Collaborate with trial manager team within the scopes of conducted trial. · Prepare ICFs from the draft/scratch. · Review medical safety information and update medical related information from the scientific databases (PubMed). Show less