Description
Summary * 10 years of work experience in Clinical Data Management * Currently serving as Data Team Lead in global studies and also as an Associate Manager in Clinical Data Management. * Possess the ability to adapt to any situation and work well with others through effective communication and interpersonal skills Experienced with data management tools processes and therapeutic areas * Responsible for leading the DM team and for timely delivery of the Data Management deliverables * Current responsibilities include timely delivery of quality databases that meet customer requirements, managing projects, resource planning & utilization, monitoring of all project deliverables, attending teleconferences, problem solving, mentoring and training * Experience in working in Phase I, II, IIIa & IIIb, IV and Observational studies * Experience in working on external data such as Lab, ECG, IVRS Safety data reconciliation * Develops risk mitigation or action plans and oversees execution when appropriate. * Have a vast experience over a plethora of therapeutic areas from the project start up to the database release (lock) Worked on various therapeutic areas - Oncology, Neuroscience, Endocrine, Cardiovascular and immunology * Quality control and basic Project Management in clinical research (FDA) regulations/GCP/basic cGMP) * Exposure to Project Management in CDM starting from Implementation and Project Execution till successful delivery of Project. * Supervise and manage an assigned team of project delivery associates who manage or support studies to ensure quality, time and budget deliverables are met.