Clinical Research Supply Chain

Keerti Kalyanshetti

E-mail: ******.**@*****.*** Telephone: 919-***-****

https://www.linkedin.com/in/keerti-kalyanshetti-3425a618 Summary and Objective

As a Certified Clinical Research Professional, I possess extensive experience in clinical research operations and development, alongside strong capabilities in research project and program management, and regulatory compliance. I specialize in fostering cross-functional collaboration to efficiently lead and manage project teams. Furthermore, I am adept at developing strategic initiatives that respond to changing business demands, significantly contributing to the overall growth of the company. Skills & Abilities – Professional

• Extensive expertise in Clinical Research Trials Management, with comprehensive experience and a strong command of clinical trial design, operational execution, supply chain management and regulatory compliance.

• Served as the representative for Senior and Lead Clinical Supply Chain Managers (CSCMs) across diverse internal and external cross-functional groups. This involves engaging with manufacturing product supply teams, various Sponsors, Sites and CROs, global regulatory teams, collaborate and influence packaging, distribution, and the finance team.

• Responsible for independently forming and implementing the strategy for all major and emerging markets, country regulatory functions.

• Oversee multiple client clinical studies concurrently, adopting a patient-centric methodology to ensure exceptional customer satisfaction.

• Responsible for lead project and program management, consistently delivering exceptional and accurate results on schedule.

• Proficient in strategic planning for all phases (I – IV) of studies, utilizing it to enhance operations, sharpen focus, establish priorities, and foster collaboration to achieve objectives.

• Providing mentorship and strategic guidance to team members, cultivating a high- performance culture rooted in excellence, collaboration, and continuous growth.

• Strong knowledge of Quality System Standards, GCP, GMP, GxP environments, FDA regulations, Medical Device Directives, and ICH-GCP regulations applicable to design and analysis.

• A strong understanding of project leadership, clinical supply management, clinical operations and processing of medical device labels and documents within a document management system (DMS), TMF ensuring adherence to Standard Operating Procedures (SOPs).

• Adept at proactively identifying potential issues and developing solutions, leveraging strong attention to detail, planning, organizational, and time management skills to ensure effective project execution.

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• A resilient and empathetic team player with strong integrity, eager to learn and embrace new challenges. Possesses an independent and accountable work ethic, demonstrating flexibility and a positive, resourceful approach to completing projects and multitasking effectively.

Skills – Software

• Knowledge of Microsoft Word, Microsoft Excel, and PowerPoint

• Experience with different IRT, IVR systems

• Knowledge of Adobe and MS Project, SharePoint, Power BI, GPM, Global Gateway, Salesforce.

• Experience with Agile, SAP, SAGE, and Elvis software systems Professional Experience

United Therapeutics Corporation, Durham, NC

Clinical Supply Chain Management / Specialist II (June 2024- July 2025) Key Responsibilities:

As part of the United Therapeutics Corporation, Clinical Operations team, I supported and managed multiple global clinical trial studies.

• Forecasted clinical supply demand for multiple clinical trials and supported the clinical supply group to ensure a continuous supply of clinical materials throughout studies.

• Developed IRT (Interactive Response Technology) vendor management plan documents.

• Assisted with audit preparation and readiness for various clinical trials.

• Supported all study phases (I-IV), including startup, maintenance, and close-out activities.

• Collaborated seamlessly with cross-functional teams, including Regulatory for QP releases, Quality Assurance for TEs (Temperature Excursion) and adjudications, Manufacturing, Distribution, and external vendors.

• Coordinated the review, approval, and generation of clinical label text for study drug materials and tracked shipments to ensure timely delivery.

• Managed reconciliations and destructions for study close-out.

• Maintained accurate study documentation and eTMF (electronic Trial Master File) filings in a timely manner.

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Proactively analyzed inventory levels and initiated shipments when necessary to minimize risks to patient impact.

Therapeutic Areas: Pulmonary Arterial Hypertension ( PAH), disease and other inflammatory and immunology Study Trials – US and Global Multicenter Trials ThermoFisher Scientific, Remote, NC

Lead Global Clinical Supply Chain, Manager (Dec2021 - June 2024) Key Responsibilities:

As part of the Thermo Fisher Scientific, Clinical Supply Chain Optimization Services team, I lead and managed the below functions.

• Recognized contracted scope of services, identify new CSOS and other service line opportunities and engage business development resources accordingly.

• Implemented, communicate, and review and generate quote, inventory management plan to using supply chain techniques.

• Developed supply chain strategies for new clinical projects and initiates activities to support strategies agreed with clients.

• Provide input into User Requirement Specifications of Interactive Response Technology (IRT) medication management module and complete User Acceptance Testing if required.

• Developed and implemented consistent inventory and cost accounting policies, procedures, and operational reporting/metrics. Oversees and reports on the project / organizational unit results for senior management.

• Proactively identify potential supply chain issues, providing analysis and recommending solutions. Conduct activities in a safe and efficient manner.

• Lead study close-out activities including returned material reconciliation, inventory destruction processing and facilitating PPMs.

• Summarized the data, prepare presentations, and make recommendations for action relative to the clinical supply chain and packaging plans.

• Worked cross functionally regulatory for QP release EU /LATAM/APAC, Israel region.

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• Developed and provide clients with reports on budget forecasting and accruals.

• Work with both internal and client Project teams to ensuring consistent communication of clinical trial material supply status. Identify potential risks, define, and perform risk mitigation plans.

• Ensured temperature excursion process is performed as required.

• Established and maintain financial forecasts and monthly billing processes for assigned client projects. Assist in training and on boarding of new employees

(buddy concept) as needed.

Project Management Leadership:

Collaborates well, builds effective business relationships and brings new or alternative perspectives forward to overcome difficulty or uncertainty and builds a coalition.

• Independently managed a portfolio of complex client projects from end-to-end within the client services business, and maintain client relationships, with a focus on providing an excellent customer experience and guiding clients through the entire customer journey within Clinical Trial Services.

• Demonstrated advanced capabilities in project management and other industry or business processes. Delivers results through creative problem solving, cross-functional teamwork, and mastery of project management, team, supporting strategic development.

• Managed internal and external relationship, work closely with clinical quality team to manage the quality incident reports and CAPA corrections of study trial and supported all cross functional activities.

• Performed highly interpreting comprehensive need analyses which reflect an understanding of the customer's target market and value proposition.

• Developed supply chain strategies for new clinical projects and initiates activities to support strategies agreed with clients.

• Understanding of Clinical Trial Supply Chain Management best practice principles to develop new or improve existing business processes and appropriately documents and revises or develops associated training materials. Therapeutic Areas: Oncology Study Trials – US and Global Multicenter Trials Page 5

Grifols, Durham, NC (Jan2020 – Dec2021)

Global Clinical Trial Supply Chain, Project Manager Key Responsibilities:

As a part of the Grifols Scientific Innovation Office (SIO) and Bioscience Clinical & Pharmacovigilance group, I managed the global clinical trial material supply for Grifols- sponsored and Investigator-led clinical trials to ensure the right product is in right place at right time to meet clinical trial needs.

• Coordinated a multitude of Clinical material tactical and project management activities throughout the clinical trial lifecycle including forecasting, packaging

/labeling, distribution, and disposition activities.

• Maintained accountability of short term and long term global clinical drug and placebo supply sales and operations planning(S&OP) process, drug calculations for various protocol designs, and of inventory, expiration dates and stability data.

• Developed and review CTM training materials for investigator meeting presentations and pharmacy manuals. Initiate shipments to global depots and interfacing with CTM vendors on import requirements.

• Managed and maintain appropriate levels of CTM supplies for assigned trials throughout the lifecycle of a trial per GCP/GMP including initiating and tracking CTM shipments, shipment receipts depot inventories, site inventories, IVR-IWR functionality, randomization codes, drug accountability, and other necessary documentations as defined on a per study basis.

• Tracked CTM release on a site level, and with Regulatory and QP release approvals, on a country level

• Reviewed CTM, IVR/IWR vendor invoices for accuracy and flag discrepancies

• Performed study drug reconciliation activities and data integrity across multiple GxP environment systems -

o Protocol/SOP deviation document create and review for the study. o CAPA document review and process for accuracy. Analyze the root causes of compliance failures to fix them systemically.

o Create detailed review processes for inspection findings, non-compliance reports, and memo letters.

o Report audit results to senior management and other relevant stakeholders. o Maintain CTM files in trial-master file as per GCP. Product Technical Complaint validation (PTC) and Temperature Excursion document creation in SAP system.

o Collaborate with IRT vendors to stay informed about data changes and update the systems accordingly. Worked as QSME

Therapeutic Areas:

• COVID-19 – Trials Global Multicenter Phase II and III and US, EU and South America

(Brazil, Chile and Columbia)

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• Anti-COVID-19 Immune Globulin Trials EU only

• Immune Deficiency Trials – Global Multicenter Trials

• Hyper Immune Deficiency Trials – US Multicenter Trials. Teleflex, Morrisville, NC ( June2019- Oct2019)

Proof reader, medical device labeling department

SBM Life Science Corp, Cary, NC

QA Compliance, Supply Chain Lead (March2017 - June2019) Key Responsibilities:

• As part of the Upstream Supply Chain and Packaging Innovation & Technology team, I completed creating Bill of Material (BOMs) of more than 200 pesticide/fertilizer products.

My main responsibilities:

• Supported Procurement and recommend improvements to boost performance and/or reduce cost by collecting and analyzing packaging and supply chain data.

• Support and recommend improvements to systems and procedures for creating, maintaining, communicating, and securing Supply Chain systems and services.

• Supported the optimization of “Standard Operating Procedures” by creating and maintaining documents in alignment with department development of key work processes.

• Managed the processing of Packaging Consumer Complaint samples by receiving samples, conducting preliminary review of defects, maintaining a log of samples received, sending designated samples to vendors, and communicating as needed with SBM’s Consumer Affairs group.

• Supported Strategic Sourcing Manager by completing activities including but not limited to GxP environment:

o Vendor Setup and Credit Application

o Updating packaging price list formatting to allow easy uploads to SAGE Page 7

o Analyze SAGE data to provide insight to purchase volume by packaging category, price comparison between vendors and purchasing trends with SBM’s spend.

o Review price discrepancy data as requested to ensure invoice pricing matches SBM’s latest price sheet

• Performed data entry, migration, organization, reformatting, and ongoing maintenance in various systems/databases.

• Verified regulatory compliance, accuracy, and version control of all new and revised versions on labeling components.

IQVIA (Quintiles) Durham, NC (May2016 –March2017)

Clinical Trial Assistant

Key Responsibilities:

• Successfully reviewed, submitted, managed, and archived all Global/Worldwide Clinical Trials Data Documents of Multiple Sclerosis Project Trials and reconciled and manage Trial Master File (TMF), Electronic Document Management Systems (EDMS) various country and site regulatory specific files, leading to on time completion of the late phase research for the drug under trial.

My main responsibilities:

• Conducted (TMF) Trial Master File review utilizing established checklists, as well as comparison of paper TMF documentations to documentation in electronic form as GxP environment.

o Reviewed General TMF, Country specific files and site-specific data documents o Updated all Company’s standard TMF index documents tracking, and filing of paper and electronic clinical trial documents

o Supported the CTA team in the preparation, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and SOPs. o Reviewed and reconcile IRB submissions, SIV documents, regulatory forms, IRB/IEC documents, case report forms (CRF), Investigator Brochure (IB) documents and regulatory aspects of protocols and clinical trials. o Contributed to regulatory submissions to support post-market administration/activities, e.g. preparation of variations to product approval. Supported the regulatory assessment of proposed changes. Page 8

o Reviewed QA and/or checking, as appropriate, of documents prepared by other unit expertise. Plan and track designated project activities including financial tracking

o Supported to designated regulatory activities as required and provide information based on regulatory requirements.

Verified the eCRF documents against paper CRF documents for accuracy and completeness.

Reviewed IEC/IRB composition, GCP compliance statements, Clinical trial related site agreement documents, insurance certificate, site payment documents, delegation activity document and other regulatory documents

• Performed all clinical Operations and Administrations of ad-hoc site review of additional site files /documents based on paper TMF findings Therapeutic Areas: Multiple Sclerosis Trials – US and Global Trials ICBio Innovative Center for Biosciences Bangalore, India (Jan2010 - Dec2013) Clinical Research Coordinator

Key Responsibilities:

• Worked as Clinical Research Coordinator and Corporate Trainer/ Educator at Provided strategic leadership, monitoring site activity, organization, training, and support and assist project team Lead CRAs, and Project Managers, team, and other project management teams.

My main responsibilities:

• Provided classroom training on Clinical Research topics ICHGCP Guidelines, Regulatory Documentation, FDA Rules, and Regulations and 21 CFR part 11, and create training material on the above topics and execute.

• Performed all clinical operations GxP Implement and require Good Documentation Practice (GDocP) in all written documents and SOPs, project management and administrations of independent and dependable work in preparation and coordination of study submission and other appropriate verify documents (DMS), Assist other staff members in completion of work in a team-oriented fashion

• Performed Quality Assurance/Quality Control of Study Diabetic trial and supported all site activities.

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• Ensured accurate documentation of evaluation and investigation results with the assigned complaint records.

• Communication, Teamwork and Compliance support research, develop programs and policies for the Center and able to work as a productive member of a team by helping develop solutions to meet group needs as well as the structure of the project management team

Therapeutic Areas:

Diabetic Trials – South India Region Only

Team Lead/Science STEM Educator (Jun1998 -Jan2010) Certifications

• Thermofisher: Certification GLB Qualified SME Trainer (QSME) Qualification.

• LinkedIn Learning:

Digital Transformation in Supply Chains

The Data Science of Healthcare, Medicine, and Public Health

Artificial Intelligence and Business Strategy

Supply Chain Analytics Foundations

International Logistics

Agile Foundations

• Grifols: GXP and GMP Training Certification NC, USA

• Barnett Educational Services:

Fundamentals of ICH- GCP Training NC, USA

Good Clinical Practice for Clinical Trials, NC, USA

• Quintiles IQVIA: Fundamentals of GCP Accreditation Exam NC, USA

• Teleflex Medical Europe Ltd:

Global Complaint Training and Project Management

Annual Standards and Regulatory Requirements Training, NC, USA

• SBM Life Science Corp: Label Review Training by EPA NC, USA

• Wake Tech: Good Laboratory Practices- FDA and EPA Regulations NC, USA

• Heart Saver: CPR and AED Certification NC, US

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Education

• ICBio Innovative Center for Biosciences (Pvt)

Advanced Diploma in Clinical Research and Clinical Data Management, Bangalore, India

• M Sc - Karnataka University,

Master of Science in Zoology Studied Molecular Cell Biology, Entomology, and Immunology, Environmental Biology, Modern Genetics and Biochemistry as part of the graduate program, Dharwad, India

• B.Sc. - P.C Jabin’s Science College,

Bachelor of Science in Botany, Zoology and Chemistry, Hubli, India Leadership and Professional Development

• Participated in International Conference on Health Care and Clinical Research, on 2010 at J.N Tata Auditorium, Indian Institute of Science (IISc), Bangalore, India Conducted by ICBio Clinical Research (pvt) ltd.

• Helping Communities, Volunteering at American Red Cross.

• Participated Entrepreneurship Awareness Camp conducted by Center for Entrepreneurship Development of Karnataka (CEDOK)

• Undertook specialized field work in the fields of Botany, Entomology, Animal Development and Economic Zoology during master’s program

• Attended scientists’ workshops in Reproductive and Developmental Biology

• Attended Online Leadership Excellence & Executive programs

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