Clinical operations manager in Boston, with large Pharma!
Clinical Data Management (CDM) resides within the Data Management and Programming Function in the Department of Biometrics, Health Outcomes and Payer Support (BHOPS) in US Medical Affairs (gMed). Members of the CDM group are allocated to work in one of three Disease Biology Areas (Bio-Oncology, Autoimmune/Ophthalmology/Asthma and Virology/Specialised Products) and report to the Head of Data Management for the individual Therapeutic Area. This position will be working within Bio-Oncology. - Manage trial/study activities from Study startup to Database lock including ongoing data listing reviews across all assigned clinical trials, studies and other investigations to continuously assure completeness, accuracy and internal consistency of all clinical data collected, which includes collection of any laboratory safety data and/or ancillary data sources, such as academic labs, ECGs (Electrocardiograms) pK (Pharmacokinetic) data, etc. - Effectively and efficiently oversee and guide data management in commercial-sponsored clinical trials, other studies and investigations to ensure consistent, accurate, thorough and appropriate data are being obtained, tracked, reported and are accessible. - As part of Vendor Management, responsibility for managing budgets and overseeing the work of external vendor partners, including vendor partners supporting the work of Clinical Data Management as well as CROs (Contract Research Organizations) themselves. - The DM works closely with the Medical Director and Drug Safety, to ensure there is ongoing Medical Review of the clinical data. - Provide timely, accurate and adequate responses and inputs to/into internal and external questions, documentation and materials. Work with other Clinical Data Management staff members to develop, implement and maintain gMED Clinical Data Management SOPs, DOPs (Standard and Departmental Operating Procedures), other processes, practices, standards, systems and tools - Members of the CDM group use a variety of tools to assist them with their responsibilities, including clinical data browsers (such as Hyperion Brio), SAS, and Electronic Data Capture (EDC) Systems, such as Oracle Inform or Medidata Rave. If you are interested in the above position please reply with your most recent resume and rate within a short notice.
Related projectsSearch for freelance jobs
can’t wait for more clients
and advertising. Thank you."