Sandhya Rani V.

Vendor selection with quality standards and contribute in the development of agreements or contracts/amendments for outsourcing services. Main line of communication between the Sponsor(s) and internal team. Taking the lead from the Sponsor and undertaking their requirements. Templates of CDA and MSA shall be shared with the sponsor for their review and approval. If sponsor shares directly, it should be shared with the legal advisory team prior proceeding further. Planning the study by coordinating with the Investigator and check for feasibility. Collecting the requirements and timelines from the Sponsor and sharing them with Medical writing department for protocol designing. Sharing the drafts of protocol, CRF and ICDs with sponsor for inputs. Once the approval is ready, status of BENOC, IP’s, T-License, method development, method Validation should be updated. Once all the documentation is ready, slotting and study schedule should be prepared. Getting approval for slots from the internal departments and checking the man-power for the study is sufficient. Study slots shall be shared with respective sponsors after approval from the internal teams. Updating the information to internal departmental HODs, Sponsor and study monitor in case of any delay or postpone or prepone or cancellation of the study. Identification of sponsor leads Appointments with the sponsor to be fixed and attend the meeting. Weekly updates to be provided to VP – Operations. Regular study updates should be sent to the Sponsor and IEC team. Interacting with the Sponsor for any further requirements from internal team or vice versa Checking the study completion within the designed timelines by interacting with internal team. Shipment of samples for the Sponsor identified site (For clinical only study). Follow-up of BA activities. Collecting the report from the internal team and sharing them with the sponsor within the Timelines.

Overall in charge for the study which includes Planning and Presentation of clinical research study information, obtaining ICF, Audio video recording of consent process, Supervision of study related activities like day custodian duties, drug administration, meal distribution, check in, check out, ambulatory activities and clinical data review (compliance with Protocol and GCP). Coordinating and being responsible for the preparation of study documentation materials such as CRF, protocols, Clinical reports, Informed Consents, Blood sample collection record and Dispensing labels. ICF registration and Presentation, Obtaining ICF. Preparation of clinical study updates and status reports of the clinical study for IEC submission. Participate in all the activities of the Clinical Operations department, like departmental meetings, SOP trainings and refreshment trainings. Preparation, review and revision of SOP’s. Managing the team for the respective studies (nursing staff, phlebotomy staff and custodians). Managing the PK samples and shipments to bio-analytical department. Point of contact for monitors and sponsors for the assigned studies. Reporting of AE’s and SAE’s to the Sponsor and IEC. IP management. Setup and maintain TMF and archival of TMF’s. Verification of all the Logbooks, calibration documents, ensuring all the Instruments in the clinic are calibrated within the date and reporting the same to the supervisor. QC of clinical study documents like TMF, CRF, Protocol, ICD, Reports and study data files etc. Vendor selection with quality standards and contribute in the development of agreements or contracts/amendments for outsourcing services. Training of New/existing employees/ study site personnel on protocol, GCP, relevant study procedures, standard operating procedures.

Provide support to the Clinical Trial Leader (CTL) with many of the tasks involved with the smooth running of clinical trials in compliance with Novartis processes. Help, manage clinical, regulatory and study-related essential documents such as study protocols, Case Report Forms, Informed Consent Forms, CSR etc.; review documents like ICF, CRF, MVR’s for completeness, accuracy and compliance with protocol and appropriate regulations. Identify issues and take appropriate corrective action as necessary. Liaise with contract organizations, vendors and other suppliers to ensure study deliverables are met. Provide input on agendas, create materials, liaise with meeting planners and coordinate logistics for key meetings. Ensure accuracy of clinical trial databases and resource tracking tools providing information and following up questions as necessary. Assist in the forecasting, identification and ordering of clinical trial supplies. Responsible for setting up and maintaining Trial Master Files and ensuring all relevant study documents are filed and archived based on the appropriate guidelines. Attend at least 1 Investigator/Site Initiation Meeting and/or 1 First Dose/Monitoring Visit and assist the CTL in organizing, conducting the meetings and sending MOM’s. Conduct, manage and document site training, site initiation, monitoring and close-out visits according to Good Clinical Practice and Novartis processes. Ensure study progress is according to timelines, budget and quality standards and provide updates to Planning and Operational Coordinators accordingly. Arrange for all necessary center payments as per financial agreements Serve as the primary Novartis contact for site study manager and investigator at clinical site Clinical registry of Trails before FPFV Set up and maintain the Trial Master File for assigned studies. Arrange for Archival as per the procedure and shipment of study files to central archival. Scan and Import of study documents.

Responsible for preparation of study documents, ICF, protocol, blood sample collection records, dispensing labels, monitoring of dosing, phlebotomy, food consumption, volunteer interaction and documentation, Calibration, Review of file s and Archival.Coordinating and being responsible for the preparation of study documentation materials such as CRF, protocols, Clinical reports, Informed Consents, Blood sample collection record and Dispensing labels. ICF registration and Presentation, Obtaining ICF. Preparation of clinical study updates and status reports of the clinical study for IEC submission. Participate in all the activities of the Clinical Operations department, like departmental meetings, SOP trainings and refreshment trainings. Preparation, review and revision of SOP’s. Managing the team for the respective studies (nursing staff, phlebotomy staff and custodians). Managing the PK samples and shipments to bio-analytical department. Point of contact for monitors and sponsors for the assigned studies. Reporting of AE’s and SAE’s to the Sponsor and IEC. IP management. Setup and maintain TMF and archival of TMF’s. Verification of all the Logbooks, calibration documents, ensuring all the Instruments in the clinic are calibrated within the date and reporting the same to the supervisor. QC of clinical study documents like TMF, CRF, Protocol, ICD, Reports and study data files etc. Vendor selection with quality standards and contribute in the development of agreements or contracts/amendments for outsourcing services. Training of New/existing employees/ study site personnel on protocol, GCP, relevant study procedures, standard operating procedures.