Senior Clinical Project Manager

• Sep 2022 - Present

Clinical Lead II

• Jun 2021 - Sep 2022

• Overall management of clinical portion of the trial. • Oversee and monitor CRAs in a matrix environment, direct involvement in selection and activation of investigative sites. • Create and ongoing maintenance of CMP, Review and approve monitoring reports • Ensure compliance through identification/mitigation of risk and ensuring adherence to ICH, GCP, SOPs, and the study protocol over the life of the study. • Drive the successful activation of trial sites according to time, quality/scope and budget parameters • Plan and drive both patient recruitment and retention, inclusive of preparing and executing a site and patient recruitment and retention plan/strategy. • Drive the clinical team forward to meet contractual milestones. • Complete/contribute to the review of the protocol/study design, informed consent forms. • Assist the project team in the creation and maintenance of the Trial Master File. • Work with the diverse stakeholders to identify data/process related issues and risks to clinical activities; assist in the development of mitigation plans to minimize risk; contribute to the risk management plan and contribute to set up of adaptive risk monitoring system on an ongoing basis • Apply a risk-based quality management system, mitigate issues, and provide support for study audits and responses • Participate in Bid Defense activities

Principal CRA

• Aug 2019 - Jun 2021

• Conduct site qualification, initiation, monitoring, and close-out visits according to ICH-GCP, SOPs, and applicable regulatory requirements • Responsible for overall site management for assigned sites • Lead CRA on the projects, acting as the primary contact for monitoring/site management related questions and Monitoring Plan development/maintenance • Mentor and facilitate training for new CRAs • Conduct site qualification, initiation, monitoring, and close-out visits according to ICH-GCP, SOPs, and applicable regulatory requirements • Responsible for overall site management for assigned sites • Lead CRA on the projects, acting as the primary contact for monitoring/site management related questions and Monitoring Plan development/maintenance • Mentor and facilitate training for new CRAs

Sr. CRA II

• Nov 2017 - Aug 2019

Site Management and Clinical Operations management for Hematology and Oncology clinical trials (Phase I and Phase III Studies) Site Management and Clinical Operations management for Hematology and Oncology clinical trials (Phase I and Phase III Studies)

Senior Clinical Research Manager

• Nov 2014 - Nov 2017

Responsible for providing strategic direction and implementation of research and project(s) design. Guides, develops, and executes project(s) strategy and work plan. Participates in developing and managing the budget. Oversees project(s) and program evaluation, ensuring compliance with partner organization protocols, applicable government regulations, and organizational policies. Manages critical relationships with stakeholders. Subject matter advisor for other programs and projects. Performs a project management role for ensuring the delivery of successful projects in accordance with project deliverable and success criteria.

Clinical Research Manager

• Dec 2013 - Nov 2014

Sr. Program Officer – Clinical Trials

• Jun 2012 - Dec 2013

Responsible for managing large pivotal and multicentre vaccine efficacy clinical trial in India in partnership with an Indian manufacturer to evaluate the safety and efficacy of a new vaccine aiming for market authorization in India and subsequent World Health Organization pre-qualification. Acting core team member of clinical operations and responsible for clinical operation including CRO oversight and ensuring study is managed by CRO as per written contract and agreed timeline. Responsible for Reviewing status reports for clinical operation and data management from CRO, Provide input in the agreements with partners, trial sites, laboratories, clinical research organizationsProject Planning: Develop strategic project plans, monitor progress of clinical studies with project planning and forecasting. Provide strategic planning expertise on clinical development plans and scenarios, Charting and implementing project plans, study specific management plan, recruitment plans for the study.Manage and communicate to senior management overall clinical strategic operations plan for projects including time lines, key deliverable and key data issues. CRO management: With primary responsibility monitoring the overall progress of clinical studies. Defined and developed systems to ensure smooth communication between Sponsor- CRO enabling strategies which helped better planning and execution of outsourced studies. Vendor management: Managing Clinical Supplies to validate study IP needs, specifications, packaging, shipment (including resupply) of supplies and reconciliation process. Ensure preparation and proper responses to audit/inspection reports, consolidation of findings, generating a corrective action plan and communicate important observations to clinical team and management.Review and approve monitoring reports; follow up letters, newsletters and investigator meeting presentations.

Sr. CRA

• May 2010 - Jun 2012

•Project Planning, preparation and review of study specific procedure documents and mentor the new team members. •Negotiation for site budget and contract. External Vendor Management. •Perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice. •Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas. •Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues. •Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues to Project Manager.

Sr. Clinical Research Associate

• Nov 2008 - Aug 2010

•Perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice. •Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues to Clinical Team Lead (CTL) and/or line manager. •Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. •Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports and other required study documentation

Clinical Research Associate

• Nov 2007 - 2008

Clinical Research Associate

• 2006 - Nov 2007