Clinical Operation (G-10) - Bangalore

Summary:- The Senior In-House CRA independently manages centralized clinical trial activities and serves as a key operational partner to Clinical Trial Managers (CTMs). This role focuses on risk-based monitoring (RBQM), eTMF quality governance. This role acts as a strategic partner to Clinical Trial Managers (CTMs), ensuring proactive risk identification, data integrity, and inspection readiness across clinical trials for medical device studies Technical Responsibilities: • Subject Matter expert in Medidata EDC systems and clinical trial tools • Contribute to development of RBQM frameworks, dashboards, and best practices • Leads execution of Quality and Risk Management planning in alignment with study and program activities • Provides strategic oversight and operational support to Lead Monitors and Clinical Study Managers in the management of investigational sites, ensuring proactive tracking of study timelines, identification of risks, and consistent compliance with protocol requirements, study plans, regulatory standards, and SOPs. Drives quality, efficiency, and inspection readiness across clinical trial activities • Mentor and guide junior In house CRAs and Interns • Performs essential document collection, review, maintenance and close-out activities, ensuring that sponsor and investigator obligations are being met and are in compliance with applicable local regulatory requirements and ICH/GCP guidelines. • Performs study tracking via the CTMS or Sponsor designated system to ensure that the study files are current, accurate and complete. • Documents site and Sponsor contact and study interactions in a timely and professional manner. • Performs study duties in adherence to the protocol, Clinical Management Plan (CMP), study processes, ICH-GCP and any other requirements stipulated on the study. • Provides oversight and strategic support for Investigational Product accountability, subject screening and enrolment performance, and Case Report Form (CRF) completeness. Ensures efficient query generation, tracking, and resolution with investigational sites, driving data quality, timely issue resolution, and compliance with protocol and regulatory requirements. • Leads the development, review, and optimization of Informed Consent Form (ICF) templates, ensuring alignment with protocol requirements, regulatory guidelines, and ethical standards, while driving consistency, clarity, and inspection readiness across studies PREFERRED QUALIFICATIONS • Bachelor’s degree in Life Sciences or related field (master’s preferred). • 5–7+ years of clinical research experience, including monitoring or centralized monitoring. • Strong understanding of RBQM and inspection readiness expectations. • Demonstrated ability to manage multiple studies and stakeholders • Experience in medical device industry Technical Skills: • Strong Knowledge on document management and Good Documentation Practices (GDP), ensuring TMF quality, completeness, and inspection readiness. Leverages extensive experience in internal and site auditing to proactively identify gaps, drive corrective and preventive actions (CAPA), and strengthen overall compliance and quality oversight across clinical trials • Development of procedures, process metrics and dashboard • Systems - Microsoft Office, eTMF (Medidata) or Veeva Vault is required, Smartsheet, PowerBI, EDUCATION REQUIREMENTS • Education – Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or related field • Holds valid GCP / ISO 14155 certification or a post graduate degree in clinical research and • has good understanding of medical and clinical research terminology (neurovascular preferred)