Project Management Medical Imaging

Anju Kumari

Hyderabad ****** Mob. No. 974******* Email ID. ********@*****.***

SUMMARY

Experienced Medical imaging Clinical Project Management with a background in overseeing clinical trials and managing cross-functional teams. Proficient in ensuring adherence to protocols, maintaining project timelines, conducting risk assessments, and preparing reports for regulatory bodies. Skilled at utilizing technical tools for data management and demonstrating effective communication skills. Past work

demonstrates significant impact on improving efficiency of project delivery while maintaining compliance with industry regulations.

SKILLS

•Imaging Vendor Management

•Experience working with Medical

Cross-Functional Team

Imaging Core Applications and Leadership software

Investigator Brocher

Risk Assessment and Mitigation

Clinical Study Report

Project Planning

Clinical Documentation

Effective Communication

Training and mentoring

Negotiation and Conflict

MS Office packages

Clinical Trial Management System (CTMS)

Image transfer systems AG Mednet and Ambra Health

HIPAA Compliance

EXPERIENCE

Accomplished medical imaging and project management and operational support for the imaging component of clinical trials across therapeutic areas like Oncology, MSK with over 5.2 years of experience at PAREXEL International/Calyx.

Provided Centralized BICR review criteria, time to time sharing training points to Radiologist as per protocol. Worked closely with Internal and Client KOI in End-to-End Project management.

Experienced in both client-facing and internal roles, contributing to the success of global clinical trials in the medical imaging domain.

Prior experience as Clinical research project management professional with over 5 years with PPD and Quintiles. Expertise in CTMS, IWRS, EDC system for clinical trial studies.

Senior Annotation Specialist 25Nov2024 – till date Horizontal Talent Group (Client – Medtronic Engineering and Innovation Centre)

Lead the annotation and labeling of complex medical images (CT, MRI, X-ray, ultrasound) for AI and machine learning model development.

Ensure data relevancy and acceptance by evaluating medical images before annotation to verify their suitability for annotation and AI modeling.

Validate annotation outcomes to guarantee accuracy and consistency, ensuring that all annotations align with clinical objectives and meet required standards.

Work closely with radiologists and clinical experts to validate annotations and ensure clinical accuracy.

Support medical communication and develop subject matter expertise for the assigned therapeutic area.

Collaborate with data scientists and machine learning engineers to refine annotation processes for optimal AI model performance.

Optimize and enhance annotation workflows by leveraging advanced tools and technologies.

Perform quality assurance audits on annotated datasets to ensure compliance with project and clinical standards.

Mentor and guide junior annotators, providing quality reviews and expert feedback.

Stay updated on the latest advancements in medical imaging and AI technologies to continually improve annotation methods

Assist the assigned scientific communication team in conducting comprehensive publication-need analysis

Scientist, Medical imaging & Scientific Operations 17/Mar/2022 – 31May2024 Calyx International Hyderabad, India

Provides project management and operational support for the imaging component of clinical trials across all therapeutic areas.

Directly involved in project related aspects of application development, medical documentation, and reviewer quality control from a medical / scientific perspective in consultation with the relevant Client SMEs and internal stakeholders.

Ensured timely completion of study-specific activities and deliverables by coordinating with both internal teams and clients.

Directly involved in preparation and review for medical imaging project related documentation like Protocol Amendment, Image review Charter, Imaging Manual data transfer form, Project management Plane review, Communication plan review etc.

Provided Best overall Study report and Endpoint adjudication Report for Client before data export and interim data review.

Served as scientific lead for the assigned projects for scientific input and support as required to evaluate safety or efficacy of investigational drugs or medical devices.

Managed 17+ Phase I – III studies including RECIST 1.1, mRECIST, iRECIST, Lugano (both PET & CT based), MSK.

Identified key data insights through patient-level review and trend analysis.

Supported as a lead for interim analysis, database lock and site central discordance activities.

Provides operational guidance to team and sites along with clinical team training and education

Provided central reviewer training for the project BICR review criteria, time to time sharing training points to reviewer as per protocol.

Ensured consistent application of protocol level deviation and study assessment.

Led studies in maintenance or in closeout phase or ongoing studies post primary database lock, as assigned.

Maintained accuracy of trial information in all trial databases and tracking systems. Attended relevant meetings to support ongoing execution of clinical trial and program level activities.

Maintained a good collaboration with cross-functional study team members for program specific standards/activities (e.g., eCRFs/oCRFs, UAT testing, database specifications, Data Validation plan, outsourcing specifications including medical imaging, data monitoring, Export report and data transfer specifications) are applied to the clinical trial, where applicable.

Team Lead, Medical Imaging- Project Management 06/Apr/2019 – 17/Mar/2022 Parexel / Calyx International, Hyderabad, India

Led and managed project teams to ensure successful delivery of imaging-related tasks in alignment with study priorities set by OWM/PM/IOL.

Coordinated project team activities, ensured clear communication across locations, and provided ongoing support to ensure team goals were achieved.

Drove data reconciliation efforts and collaborated with teams to resolve technical and operational issues.

Provided input on special skill set requirements, contributing to the expansion of subject matter expertise within the department.

Assisted with project documentation and ensured adherence to confidentiality requirements, maintaining the integrity of study protocols and subjects.rao

Prepared, monitored, and supported day to day task of the project team members based on study priorities set by PM/IOL.

Lead initiative within the Calyx imaging group for imaging vendor training to internal Calyx team members to bridge the gap between sites, internal team members, imaging vendors to create a more harmonious relationship.

Ensures delivery of image data per pre-defined timelines and specifications while performing risk management and monitoring imaging issue resolution.

Provided feedback and evaluated content of project plan, CIL, IAG and SOM to ensure appropriate documentation of all operational activities.

Identifies issues and work with PM and IOL to determine best course of corrective action for resolving them.

Ensures that confidentiality of study protocols and subjects is being maintained.

Assisted in performing quality checks on study images if required.

Assisted in performing Site and Project team trainings if required.

Executed Technical and clinical functions as required by the study protocol in accordance with GCP and SOPs.

Performed other duties as required by the position.

Project Assistant 09/Feb/2015 – 08/Jun2018 PPD Development LLC, Bangalore, India

Oversee the execution and dissemination of study related information, including project tracking updates to clients, clinical study teams and other PPD departments.

Coordination of eTMF/Project file set up.

Upon direction of CTM/PM, finalize the table of content for all study files (Central, Internal, Country, Investigator), develop and distribute filing guidelines to clinical team.

Performed file reviews and data reconciliation and log outstanding issues in project related tracking tools.

Reviewed Submission of documents to Central and Internal files and update in CTMS.

Assisted in the creation of study specific documents and plans (e.g. Communication Plan, Project Plan, Monitoring

Plan, monthly Status Report etc.), study logs (e.g. Drug Accountability Log, Site Visit Log, etc.), study trackers (e.g. Training tracker, FAQ, etc).

Clinical Trial Assistant 06Jan/2014 – 02/Feb/2015 Quintiles, Bangalore, India

Processed Reimbursement payment to the investigator and sites for study visit forms.

Generated invoices for study visit forms by using EDC (Electronic data capture) System.

Generated quantitative and qualitative periodic update for reimbursement payment by using (Electronic data capture) EDC system.

Coordinated respective study Trial master file document with PEFD (Project email filling database) and PSO (Project support office).

Migration end-to-end of study level data into the Clinical Trial Management System (CTMS).

EDUCATION

Orissa University of Agriculture and Technology- Bhubaneshwar MSc. Bioinformatics Year 2011

Andhra University – Vishakhapatnam BSc. Biotechnology Year 2009

Diploma in Clinical Research, Clinical data Management and Base SAS Year 2013

DISCLAIMER

I hereby declare that the above-mentioned information is correct up to my knowledge and I bear the responsibility for the correctness of the above-mentioned information.

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