Biosite Research Private Limited

Bangalore, Karnataka

Perform day-to-day accounting transactions like Journal entries, payments, receipt entries, refunds, reimbursements, and adjustments in Zoho books- Reconciling the Bank Statements.- Reconciling the Goods and Services Tax.- Generating Sales invoices to foreign and domestic clients.- Creating milestone invoices to the Sponsors in respect to the study.- Payment follow up with Clients.- Invoice Processing (Both inward and outward).- Updating Payables and Receivables.- Coordinate with banks on a regular basis for foreign remittance, etc- Regularly update data for GST and TDS filings and share it with CA.- Compute and make statutory payments on time for TDS, GST, PF, ESIC, Income Tax, etc.- Processed Employee Pay check and Other Key Financial Transaction Details.- Deduct the right TDS amounts while transferring Payments and salaries.- Processing and reviewing Ethics Committee Invoices in accordance with EC SOP.- Keeping a track of study related Expenses.- Releasing site Fees in Accordance with the clinical Trial Agreement.- Reviewing and processing Monitoring Expenses.- Provide clarifications on queries raised and provide documents where necessary during audit.- Co-ordinating with the Auditors on all Audit Procedures.- Creating Enduring Relationship with both potential and Current Clients.- Maintaining Accuracy of journal entries and updating the records.- Control over Complicated Expenses Reporting.- Create, Evaluate and submit Budget plans for Business Objectives

Perform core medical monitoring activities for multiple assigned studies, including input into study design, protocol and regulatory approval strategy, Prepare and execute successful SEC Presentation in CDSCO meetings. Response to inquiries from the sites, regulatory authorities, IRBs/IECs Responsibility for the management of all medical issues which arise in the course of the clinical study (Phase II IV/PMS), presentation to investigator meetings, safety review committees. Write the study Medical Monitoring Plan (MMP) in co-ordination with the Safety Monitoring Plan (SMP) Perform the medical review of patient data and patient profiles during the study period and provide input for the clinical study report (CSR). Provide medical oversight of assigned studies, including medical monitoring, evaluation of patients eligibility, interpretation and appropriate management and reporting of patient safety data throughout the lifecycle of the study in accordance with ICH Good Clinical Practice, applicable regulatory guidelines and company standard operating procedures. Review adverse events (AEs), serious adverse events (SAEs) and AEs of Special Interest, and participate in safety signal detection activities to identify emergent safety concerns and recommend appropriate action. Provide medical expertise, guidance, and therapeutic area training of project team as required. Act as medical advisor to project manager when required. Guide Statistics Analysis Team during Data Analysis for CSR.