Renuka Kelapure
Clinical Project Manager @IQVIA
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WORK HISTORY
Clinical Project Manager @IQVIA
US
Lead core project teams across clinical studies, ensuring delivery meets contractual, operational, and quality requirements.Strategically plan and execute multi-country, multi-service, and multi-regional clinical trials in alignment with SOPs, policies, and study tools.Develop integrated study management plans with the project team, translating project strategy into actionable execution.Foster cross-functional collaboration to drive productivity, quality, and strong financial performance.Identify, assess, and mitigate project risks; lead issue resolution and implement corrective/preventative actions.Coordinate with clinical teams to streamline operations and bring new therapies to market more efficiently.Act as the primary client liaison, maintaining strong relationships to enhance satisfaction and promote continuous improvement.Participate in and lead bid defense preparation and presentations in collaboration with Business Development.Monitor project progress against contractual obligations; proactively communicate status updates to internal and external stakeholders.Ensure project compliance with regulatory standards, manage project documentation, and optimize operational efficiency.Lead forecasting, identify scope changes, and manage change control processes to drive revenue acceleration.Identify and share lessons learned to foster continuous improvement and innovation in clinical project management.Support professional development of junior team members through mentoring and performance feedback.Collaborate cross-functionally to overcome study-related obstacles and achieve key milestones.Provide input to functional managers on team member performance related to project work.
EDUCATION
Gilings School of Public Health , University of North Carolina, Chapel Hill
M.H.A, Public Health, Health Care Administration, Business Administration
Shri Vasantrao Naik Government Medical College, India
MBBS, Medicine and Surgery
Northeastern University
Data Analytics and Machine Learning Certification , Data Analytics and Machine Learning
SKILLS
ABOUT RENUKA KELAPURE
Early Clinical Development, Project management, strategy planning, finance, accounting, clinical trial budgets and contracts, people management, RFP writing, proposal creations, bid defense, data management and integration, bio stat understanding, medical writing, study closeout, timeline management, Pharmacovigilance. • Vendor management including CROs• Knowledge and experience in SAS, SPSS, Jreview, Spotfire, Tableu, R and R shiny programming, My SQL, excel and Microsoft suite • Managerial roles in clinical medicine as Chief Medical Officer as well as in Clinical research. • Management of multiple clinical trials according to GCP, ICH guidelines and global regulations• Managed multiple research projects including submissions of IRB applications, IND applications, authored clinical protocols, ICF/ICDs, • Supervised and trained research assistants and students and coordinators• Writing publications, abstract, and complied research budgets and contracts.• Expertise in electronic medical record systems like OpenNotes, EDCs, and IVRS. • Experience with mining and cleansing large data sets, statistics, inferential statistics, machine learning, algorithms, predictive analytics, data mining modeling, data extraction, analysis, unsupervised and supervised learning, data simulation and clustering, big data and analytics, business intelligence tools such as Tableau, R Shiny, Orange• Clinical decisions and predictive analysis, operational research models in healthcare systems, laws and ethics in healthcare, healthcare and research finance, strategy, leadership, organizational behavior, marketing and economicsSpecialties: Public Health Administration, Clinical Research, Data Analysis, Machine Learning, Modeling, Software Design, Advanced Excel, Python, Business Administration, Clinical trials, Electronic Health Records, Research Scientist Project Management, Funding proposalsTherapeutic areas - Oncology, Infectious diseases, Gastroenterology, Immunology, General Medicine, Neurology and pain studies
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