Responsible for the overall direction, coordination, implementation, execution, control and completion of multiple projects (BioPharma & medical devices) - Responsible for managing new projects with multi-functional teams; responsibilities include the planning of all project activities according to defined product development and stage gate processes, coordination of project team activities to meet project deliverables, FDA/ISO requirements, and the management of the overall project… Show more Responsible for the overall direction, coordination, implementation, execution, control and completion of multiple projects (BioPharma & medical devices) - Responsible for managing new projects with multi-functional teams; responsibilities include the planning of all project activities according to defined product development and stage gate processes, coordination of project team activities to meet project deliverables, FDA/ISO requirements, and the management of the overall project schedule, resource requirements, and budget, including progress reporting and reviews with senior management. Show less

• Lead cross-cultural and cross-functional collaboration to deploy study timelines, productivity and quality measures through regular review of clinical team communications, quality assurance and audit findings• Managed EAC phasing, forecasting and baselining for EAC, Alert Management, Study supplies/Non-IP Management, Onboarding activities and Resource Management, Clinical Operations Compliance, Risk-Based Monitoring (RBM), performed data analytics.• Managed deliverables for 25 studies… Show more • Lead cross-cultural and cross-functional collaboration to deploy study timelines, productivity and quality measures through regular review of clinical team communications, quality assurance and audit findings• Managed EAC phasing, forecasting and baselining for EAC, Alert Management, Study supplies/Non-IP Management, Onboarding activities and Resource Management, Clinical Operations Compliance, Risk-Based Monitoring (RBM), performed data analytics.• Managed deliverables for 25 studies along with Clinical Lead (CL) within study timelines and budget by setting up clinical tools and processes for the study team, compiled project data, analyzed it, and prepared reports to be presented to senior management for decision making. Show less

• Managed and coordinated project planning, schedules, monthly finance and risk management, analyzing overall effectiveness of project management across the study• Identifying & mitigating areas of bottlenecks while ensuring quality standards, SOPs, ICH and guidelines meeting local regulations. • Proficiency in developing & driving the integrated project plans, aligning project tactics with project strategy; skills to enhance maintenance effectiveness to meet operational goals within… Show more • Managed and coordinated project planning, schedules, monthly finance and risk management, analyzing overall effectiveness of project management across the study• Identifying & mitigating areas of bottlenecks while ensuring quality standards, SOPs, ICH and guidelines meeting local regulations. • Proficiency in developing & driving the integrated project plans, aligning project tactics with project strategy; skills to enhance maintenance effectiveness to meet operational goals within cost, time & quality parameters, and ultimately produce high quality deliverables Show less

• Spearheaded ‘Safety Analysis and Action items initiative’ for Asia-Pac leading to resolution of over 100k AI’s within 4 months of initiative drive; executed training program for India & China and mentoring new joinees• Delivered high level recommendations to support strategy to improve efficiency and service quality• Ensuring effective cross-functional teamwork among project team members including both internal and external ancillary services.• Supported updating and maintenance… Show more • Spearheaded ‘Safety Analysis and Action items initiative’ for Asia-Pac leading to resolution of over 100k AI’s within 4 months of initiative drive; executed training program for India & China and mentoring new joinees• Delivered high level recommendations to support strategy to improve efficiency and service quality• Ensuring effective cross-functional teamwork among project team members including both internal and external ancillary services.• Supported updating and maintenance of internal systems, databases, tracking tools, timelines and project plans with project specific information Show less

• Developed educational curriculum for new system implementation and assessed Staff performance• Oversaw facilities services, maintenance activities and tradespersons, planned and coordinated administrative procedures and systems and devise ways to streamline processes, developed systems within school to drive efficiency of management/operational activities and improve focus on instructional and pedagogical activities.

• Led clinical operations, site management and monitoring for 10 clinical studies. • Held kick-off meetings to assemble project teams, assigned tasks, and delegated responsibilities, identified resources and reviewed detailed timelines, to ensure timely completion of assigned studies.• Organized regulatory workflow, supporting regulatory submission teams, tracking submission timelines, and reviewing technical documents, maintaining IRB submissions and regulatory documents, input and… Show more • Led clinical operations, site management and monitoring for 10 clinical studies. • Held kick-off meetings to assemble project teams, assigned tasks, and delegated responsibilities, identified resources and reviewed detailed timelines, to ensure timely completion of assigned studies.• Organized regulatory workflow, supporting regulatory submission teams, tracking submission timelines, and reviewing technical documents, maintaining IRB submissions and regulatory documents, input and maintenance of the CTRI registry for global studies; supported the Ethics Committee Member Secretary• Conducted site qualification, initiation, interim monitoring and study close-out visits for Phase 2-4 studies, PMS studies in accordance with federal regulations, Good Clinical Practices (GCP), ICH Guidelines, and company related SOP’s and other business processes. Show less

• Managed 7-8 global research trials in ophthalmology – Uvea, Retina with Carl-Zeiss Ltd, Novartis, Bayer Health Care, Bausch and Lomb- Identified quality and performance improvement opportunities and collaboration with staff in the development of action plans to improve quality• Managed and coordinated all on-site activities including all protocol-related activities, GCP trainings, records, eCRF’s and stakeholder management across Sponsor, vendors and CROs. • Ethics Coordinator to the… Show more • Managed 7-8 global research trials in ophthalmology – Uvea, Retina with Carl-Zeiss Ltd, Novartis, Bayer Health Care, Bausch and Lomb- Identified quality and performance improvement opportunities and collaboration with staff in the development of action plans to improve quality• Managed and coordinated all on-site activities including all protocol-related activities, GCP trainings, records, eCRF’s and stakeholder management across Sponsor, vendors and CROs. • Ethics Coordinator to the Ethics Committee Member Secretary, handling with all confidentiality of Ethics and coordinating other related activities of the Ethics Committee. Show less