Kalyan Obalampalli (Ko) Email & Phone Number

San Francisco, Ca, Us

ClinAI is forever changing how companies select and manage Clinical Trial Vendors such as CROs, Central Labs, Imaging Vendors, etc. ClinAI’s RFP / Vendor Selection platform enables biotech/pharma companies create, send and receive proposals on the cloud – Excel Free 😊. Select the right vendors, without friction through AI-based 1:1 comparative analytics. Headquartered in San Francisco, ClinAI is a privately held company founded in 2021. Read more at https://www.clin.ai

South San Francisco, California, Us

• Provide strategic oversight to Clinical Trial Managers (CTM) and Sr Clinical Trial managers (Sr CTM) for multiple oncology studies in phases II- IV • Anticipate risks across project portfolio and plan to mitigate/eliminate risks • Manage resources, timelines and study budgets (within 5% variance) clinical trials at program level• Oversee study timelines, CRO and vendor performance to meet departmental and corporate goals• Accountable for all operational aspects and progress of clinical trials from study planning activities to execution• Communicate strategic and technical goals to employees at all levels• Serve as an escalation point and resource for CTMs; partner with cross functional groups to achieve deliverables• Approve metrics and updates to Senior Management as needed• Lead multiple department initiatives including branding Clinical Operations internally and externally, Data Visualization for Senior Management, etc

Abbott Park, Illinois, Us

• Provided strategic direction combined with execution on Abbott’s Structural Heart programs• Responsible and accountable for multiple clinical projects to drive aggressive program timelines• Managed multiple teams (US and OUS) towards milestones and deliverables • Worked with multiple vendors and suppliers in contract development and negotiation• Selected / provided oversight of CROs, core labs and other vendors to ensure proper trial conduct and high data compliance• Implemented innovative subject enrollment initiatives on the COAPT and other key Structural Heart trials • Implemented a comprehensive education program and a KOL management strategy for Program Management group• Designed new indication/ product approval strategies in partnership with Regulatory Affairs • Prepared and managed multiple study budgets and resource needs

Minneapolis, Mn, Us

• Knowledgeable in data collection techniques, protocol development, report writing, site management, data collection and review, good clinical practices and the code of federal regulations• Experienced on IDE, PMAs submissions involving new indications and new devices • Extensive experience working with clinical corelabs, FDA, PMDA and Key Opinion Leaders • Trained CRAs, Field CRAs, Field Clinical Specialists, Clinical Data Analysts, Investigators and site study staff on study protocol and processes.• Managed Investigational Plan, budget, contracts, staffing resources and timelines for clinical trials• Lead the clinical core team in coordinating study activities, such as collecting, reconciling and reporting clinical data for the study• Wrote multiple protocols, annual reports, clinical updates and CERs • Provided daily work direction to other members on the project team• Ensured quality by maintaining high compliance (highest among similar competitor studies), reviewing adverse events and device complaints, reviewing audit reports and implementing corrective actions• Designed new indication/ product approval strategies in partnership with Regulatory Affairs (significantly reducing approval timelines through innovative clinical strategies)• Trained, prepared and supported sites during BIMO audits• Identified and implemented several quality initiatives to prevent data qualify issues within Medtronic • Effectively communicated study status updates to key management personnel on a regular basis

Us

• Created new research opportunities by introducing IDE trials to Cardiologists in the California area.• Added new research sites that are both eligible and equipped, with a proven record of performing IDE trials by building relationships with Cardiologists and their staff.• Managed IDE studies and ensured all sites reach or exceed 100% enrollment goals by consistently providing reliable support and building excellent relationships with physicians and staff.• Actively developed SOPs and DWIs to facilitate consistent study management and maintain protocol and data integrity per regulations.• Initiated and developed innovative patient recruitment strategies to help identify eligible patients and improve enrollment rates.• Provided Tier 3 technical support for IDE trials for the entire West Coast. Mentored new FCEs with proper on-field training and clinical guidance. Ensured on-field technical support and coverage for all cases.• Performed on-site training for physicians and staff, provided critical feedback and input into new product development, support in-house personnel with product enhancement.

St. Paul, Minnesota, Us

• Managed Phase I-IV clinical trials in conjunction with multiple hospitals• Hold a 100% record for goal accomplishment in maintaining integrity of protocol, regulatory and data compliance, and enrollment levels.• Started/managed more than 8 pre-market and 6 post market clinical trials.• Founding member of the Publishing Council, an internal group designed to promote/educate field engineers on how to publish and present clinical trial findings at industry conferences/publications. Success rate has risen 30% since council formation.• Developed physician and site partnerships that allowed for predictable and reliable study start and completion maintaining data/protocol compliance. • Provided direct support to all different departments as requested, including, Product Planning, Marketing, Patent submissions, product literature review and strategic planning input.• Promoted non-IDE research projects/research publications by conducting trials and developing studies in conjunction with physicians. • Supported the Sales Organizations and Clinical Education as a speaker/trainer, mentor and developer of training materials.

St. Paul, Minnesota, Us

• Responsible for designing, writing, and implementing clinical trial protocols and data collection forms (CRFs) for clinical studies (IDEs). • Coordinated clinical data collection, analyze technical data and manage adverse events.• Ensured regulatory and clinical protocol compliance for clinical projects according to ICH/GCP guidelines and FDA regulations, and assisted in expediting clinical products through the US FDA.• Conducted study site monitoring of clinical trials to ensure completeness and accuracy of data according to ICH/GCP guidelines.• Demonstrated high ability to understand complex medical concepts and to cope both with scientific and organizational aspects of Medical Devices studies by working closely with Regulatory, Development, Biostatistics and Data Management teams. . • SOP and DWI development.• Prepared IDE, PMA, and annual submissions to FDA.

• Initiate, design, develop and implement scientific research projects. • Develop, execute and supervise research protocols.• Design Virtual Instruments using LabView software for executing protocols for fibrillation studies.• Analyze data using statistical principles.• Conduct Cardiac Electrophysiology Studies.

• Handled clinical applications for Ultrasound and Color Doppler modalities. • Led a group of Service Engineers and supervised technical support of medical devices.

Ms, Biomedical Engineering

Bs- Electrical Engineering