Pradyumna Yagnam
Clinical Project Manager at WorldCare Clinical- Claim this Profile
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Bio
Valerio Ketmaier
Pradyumna is a really engaged team member, highly focused and detailed oriented. He is extremely knowledgeable, responsive and has a great sense of ownership. He has a thorough understanding of clinical trials and would represent a great added value for any team!
Pooja Choksi
Pradyumna is skilled Clincal research professional with great depth of knowledge on Clinical operations especially Imaging!
Valerio Ketmaier
Pradyumna is a really engaged team member, highly focused and detailed oriented. He is extremely knowledgeable, responsive and has a great sense of ownership. He has a thorough understanding of clinical trials and would represent a great added value for any team!
Pooja Choksi
Pradyumna is skilled Clincal research professional with great depth of knowledge on Clinical operations especially Imaging!
Valerio Ketmaier
Pradyumna is a really engaged team member, highly focused and detailed oriented. He is extremely knowledgeable, responsive and has a great sense of ownership. He has a thorough understanding of clinical trials and would represent a great added value for any team!
Pooja Choksi
Pradyumna is skilled Clincal research professional with great depth of knowledge on Clinical operations especially Imaging!
Valerio Ketmaier
Pradyumna is a really engaged team member, highly focused and detailed oriented. He is extremely knowledgeable, responsive and has a great sense of ownership. He has a thorough understanding of clinical trials and would represent a great added value for any team!
Pooja Choksi
Pradyumna is skilled Clincal research professional with great depth of knowledge on Clinical operations especially Imaging!
Credentials
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Introduction to Project Management
SimplilearnJun, 2021- Sep, 2024 -
Learning Microsoft Project
LinkedInJun, 2021- Sep, 2024 -
Strategic Thinking
LinkedInJun, 2021- Sep, 2024 -
Implementing Lean: A Case Study
LinkedInMay, 2021- Sep, 2024 -
Six Sigma Foundations
LinkedInMay, 2021- Sep, 2024
Experience
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WorldCare Clinical
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United States
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Hospitals and Health Care
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1 - 100 Employee
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Clinical Project Manager
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Mar 2022 - Present
• Point of escalation for sponsor and all other stake holders involved in study. • Utilize project management tools to plan, track, prioritize and communicate timelines and deliverables to the project team and sponsor. • Provide project updates on a consistent basis to various stakeholders about strategy, adjustments, and progress • Ensure to receive all necessary client signatures on the critical path. • Prepare and present slides on internal processes during Investigator meetings. • Conduct kick-off meeting and other study team meetings with internal and external study team members. • Develop comprehensive project plans to be shared with clients as well as other staff members • Develop project scopes and objectives, involving all relevant stakeholders and ensuring technical feasibility • Facilitate preparation of study analysis plan/ Charter. • Develop and manage a detailed project timelines/schedule and work plan, using Gantt Chart. • Manage Independent Review process. • Alert all the stake holders on any resourcing or timeline issues (e.g., Out of scope requests, System or Application issues) • Coordinate with cross-discipline team members to make sure that all parties are on track with project requirements, deadlines, and schedules. • Maintain Risk Registry and share periodically with sponsor team • Use appropriate internal applications to manage changes in project scope (CIS), schedule, and costs • Verify the correctness of study reports and ensure they are distributed to the internal and external study team members as appropriate, or filed in a collaboration area on a study specific portal • Measure project performance to identify areas for improvement using appropriate KPIs, metrics, tools, and techniques. • Lead and support mentoring of new team members. Show less
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CALYX
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United States
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IT Services and IT Consulting
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1 - 100 Employee
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Associate Project Manager
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Aug 2021 - Mar 2022
* Utilize project management tools to plan, track, prioritize and communicate timelines and deliverables to project team and sponsor.* Developed comprehensive project plans to be shared with clients and other staff members* Ensure to receive all necessary client signatures on the critical path.* Developed project scopes and objectives, involving all relevant stakeholders and ensuring technical feasibility* Provides timely notification to all appropriate parties with deviations from timelines and/or deliverables. * Maintained Risk Registry and shared periodically with sponsor team to minimize project risks* Facilitates preparation of study analysis plan/ Charter and managed Independent Review process.* Conducted kick-off meeting and other study team meetings with internal and external study team members.* Manage the study to contract, including proactive management of budget, pass-through costs, and contract amendments where necessary.* Actively manage the timelines considering impact on resources and revenue forecasting.* Created SOX Proof for monthly Client Invoices, Budget Forecast, and approvals.* Analyzed variances and initiated corrective actions* Used appropriate internal applications to manage changes in project scope (CIS), schedule, and costs* Works with Imaging Data Operations or other Subject Matter Experts to get customized reports programmed and generated within the given timelines and distributed to the internal and external study team members as appropriate* Measured project performance to identify areas for improvement using appropriate KPIs, metrics, tools, and techniques.* Work collaboratively with clinical program managers and Integration Managers to ensure delivery of the complete and seamless service to sponsors.* Maintained a positive, results orientated work environment, building partnerships and modelling teamwork, communicating to the team in an open, balanced and objective manner. Show less
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Project Management - Operations Lead
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Jan 2021 - Aug 2021
* Monitoring study progress and alert Project Manager and other involved study team members of any resourcing or timeline issues * Performed a regular quality check on central files, electronic and hard copy as applicable and take corrective action as required* Supported the Project Manager during internal and external study team calls meetings (remote or face to face) for site staff and CRAs* Monitored that site qualification, image processing and query management are performed per the global guidelines, such as SOPs and work instructions, and are completed within the defined timelines* Regularly reviewed the status of site qualification, image processing, query management* Acted as a point of escalation for site related issues* Notified Project Manager and Medical Team if team requires additional training on study specific tasks* Assisted Project Manager in setting up the data reconciliation and data QC documentation* Provided direction to the Team Leads or process group on data reconciliation activities* Assisted Project Manager in following up with Imaging Data Operations or SciMed for creation/review of data QC outlier report* Supported and/or perform case assignment for independent review on complex studies/ Provide direction to Team Leads for case assignment* Acted as liaison with 3rd party providers and/or consultants Show less
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PAREXEL
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United States
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Pharmaceutical Manufacturing
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700 & Above Employee
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Operations Lead - Project Management
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Aug 2017 - Jan 2021
* Monitoring study progress and alert Project Manager and other involved study team members of any resourcing or timeline issues* Performed a regular quality check on central files, electronic and hard copy as applicable and take corrective action as required* Supported the Project Manager during internal and external study team calls meetings (remote or face to face) for site staff and CRAs* Monitored that site qualification, image processing and query management are performed per the global guidelines, such as SOPs and work instructions, and are completed within the defined timelines* Regularly reviewed the status of site qualification, image processing, query management* Acted as a point of escalation for site related issues* Notified Project Manager and Medical Team if team requires additional training on study specific tasks* Assisted Project Manager in setting up the data reconciliation and data QC documentation* Provided direction to the Team Leads or process group on data reconciliation activities* Assisted Project Manager in following up with Imaging Data Operations or SciMed for creation/review of data QC outlier report* Supported and/or perform case assignment for independent review on complex studies/ Provide direction to Team Leads for case assignment* Acted as liaison with 3rd party providers and/or consultants Show less
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Team Lead
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Nov 2015 - Aug 2017
* Responsible for achieving team targets set by the Line manager / Project Manager.* Responsible for communicating team progress to LM/PM * Responsible for facilitating team communication across all locations.* Reports study needs and issues to the LM/PM* Collaborated with management to resolve technical/study concerns and problems.* Collaborated with management to identify resources have the needed skill set.* Collaborated with management to identify gaps in team skill set.* Assisted in managing team members work schedule.* Guides, supports, and leads the project team in carrying out assigned day-to-day tasks.* Coordinate the initiation and implementation of assigned Projects.* Communicate effectively, verbally and in writing, with all internal and external customers * Identifies and participates in the performance improvement process. Show less
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Senior Imaging Research Associate
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May 2013 - Nov 2015
Perform quality assurance checks on study images to ensure protocol specific requirements are met. Perform established image processing techniques (converting imaging formats, performing preliminary measurements of lesions and volumes) across multiple modalities (including but not limited to CT, MRI, Ultrasound) using proprietary software as well as other third party software Perform project specific tasks in compliance with Good Clinical Practices (GCP), regulatory requirements (21CFR Part 11), applicable departmental and companywide SOPs, and project specific protocols Perform demonstrations of project applications (tracking, analysis, image viewers, etc.) and image processing techniques to clients, auditors and internal personnel Assist PM and IOLs in site training visits and/or investigator meeting presentations for assigned projects Assist with the training and mentoring of Imaging Research Associates, Imaging Assistants and new hires Assist in training of independent reviewers Assist with expanding subject matter expertise for specific modalities and therapeutic areas Work closely with the product development teams to provide enhancement requirements and assist with resolving technical issues Work with Imaging Support Group to explore new tools and software to increase efficiency Effectively contribute to global harmonization processes Validate and maintain imaging database including images and tracking and review results for assigned projects Resolve project related problems and escalate issues that cannot be resolved to the appropriate party. Manage the data reconciliation process together with client or CRO data management group Issue and resolve queries with investigator sites and academic centres to ensure follow-up on imaging-related issues. Assisting project team in site qualification steps, processing of imaging examinations and query management Show less
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Imaging Research Associate II
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Apr 2010 - May 2013
1. Ensure the site personnel have a good understanding of the requirements of the study by working with investigator sites on site surveys and site qualification2. Perform quality assurance checks on study images ( including the downloading of Imaging Data from media, Digitizing, Data Entry) across multiple modalities (including but not limited to ECHO, X-Ray, CT, MRI and Bone scan) using Alice TM as well as other third party software’s (Digiview TM). 3. Validate and maintain imaging database including images and tracking and review results for assigned projectsMentor and assist in training internal personnel.4. Delivering quality work within the assigned projects of Good Clinical Practices (GCP), additional regulatory requirements (21 CFR Part 11) applicable departmental and companywide SOPs, and project specific protocol compliance.5. Maintain completeness and accuracy of image tracking study and databases6. Resolve project related problems and escalate issues that cannot be resolved to the appropriate party. Show less
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Apex CoVantage
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United States
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IT Services and IT Consulting
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500 - 600 Employee
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Junior Content Analyst
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2008 - 2010
1. Compile and summarize researched information, data and statistics into reports, documents and case studies. This involves studying and analyzing data from a broad range of disciplines. 2. Editing and proofreading of already written content. 3. Responsible for indexing the content received from the client using specific software Indexing Tool 4. Each known Text element, Figures and Tables of academic and scholarly articles will be extracted from the full text, verified the biological, geological and social terms through internet browsing and indexed to uncontrolled list of terms. 5. Coordinating and providing trainings to new team members whenever required Show less
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Education
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2003 - 2006
Loyola Academy Junior and P.G. College, Secunderabad
Master of Bio-Technology, Bio-Technology
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