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Monitoring Project Manager @JSS Medical Research
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WORK HISTORY
Monitoring Project Manager @JSS Medical Research
IN
Selection of clinical investigators/sites depending upon the study requirements• Conduct pre-site selection visits to ensure adequate facilities, qualified staff and patient population for study conduct.• Negotiating the study budgets with the Principal Investigator and executing the Clinical Trial Agreement • Preparation of study related plans like Clinical Trial Management Plan, Monitoring Plan.• Review and assist in preparation of study related documents like ICFs, source documents that are required for the study. • Provide the study specifications to Business Development team for the development of study budget and other contract agreements required by the Sponsor.• Organise Investigator Meetings in coordination with Principal Investigator’s, Sponsors and other study related stake holders. • Prepare and train the site staff for possible inspection/Audit.• To strategize for timely subject enrolment at sites by coordinating with participating Principal Investigators• Preparation of Risk Management Plans during the study conduct as required. • Monitor and track patient enrolment on regular basis and provide updates to all relevant stake holders.• Monitor APM, CRA, and study team performance and provide their assessment on quarterly basis along with strengths and weakness to the management. • Identify the study specific issues and bringing the issues to the attention of management and sponsor with proposed solutions.• Interdepartmental coordination DM, MM and QA for project deliverables, conducting internal inspections and audits. • Scheduling the meetings with the clients and kick of meetings with all study stakeholders as per the study requirements. • Taking care of Site Close Out Visit activities like collection/reconciliation of all data and returning the study supplies to the sponsor.• Ensure archival procedures are executed properly at all participating sites as per the agreement for future Audits.
EDUCATION
Raghu college
Senior School Certification
NTR University of Health Sciences
Bachelor of Homeopathic Medicine & Surgery, Medicine
University of Hyderabad
Post Graduate Diploma in Project Management , Project Management
SKILLS
ABOUT KUSUMA KIRAN
Resilient and performance driven medical professional with over 13 years of expertise in Clinical Research and Medical Imaging• Competent in query management, clinical operations, site standardization and authorization of clinical documents• Well versed with Microsoft office 97, XP, 2007,Clinicopia, Phase-Forward InForm 4.5, EmphylxJ, Air-way Inspector, Dicom Editor, Sante, Microdicom and Alice• Comprehensive knowledge of image processing techniques and ICH-GCP and GCDM standards• Excellent interpersonal, analytical and administration skills with an ability to manage the team in clinical trials
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