Clinical Study Manager Job in Chesterbrook, Pennsylvania US
Clinical Study Manager
Clinical Study Manager Clinical Research Every day, Kelly Scientific Resources (KSR) connects clinical research professionals with opportunities to advance their careers. We currently have a 1 year contract opportunity as a Clinical Study Manager for our client in Chesterbrook, PA. Job Responsibilities: · Supports the clinical team to deliver the clinical study. · Facilitate and/or attend regular internal and external study team meetings. · Monitors the progress of clinical activity and produces regular and ad hoc reports and presentations for management as required. · May support planning/execution of investigator meetings. · May negotiates budgets and contracts with investigative sites. · Maintains knowledge of therapeutic area, current medical practice and pharmaceutical regulations in order to ensure best practice across all activities. · Responsible for management/oversight of clinical monitoring of research studies, in alignment with the Clinical Monitoring Plan. Including review of clinical monitoring reports, execution at co-monitoring visits, and attendance at scheduled and/or ad hoc CRA teleconferences. · Oversees the management/oversight of CRO activities and other clinical vendors to ensure quality is consistent with Shire requirements. · Provides oversight of recruitment and retention vendor; tracks compliance review and approval of specific advertisements. · Ensure all required study plans are in place and utilized. · May author/oversee protocol amendments and or informed consent forms/amendments. · Review ICFs for site-specific and local IRBs/EBs; track Compliance review and approval. · Coordinates/oversees the on-schedule delivery of clinical trial supplies to investigative sites in collaboration with Pharmaceutical Sciences. Responsible for IMP sign-off for initial drug shipment. · Responsible for liaising and coordinating with clinical trial assistant and clinical document management specialists regarding study files. · Oversight of clinical trial assistant study related activities. · May approve protocol level documents as defined by SOPs. · Assist with ongoing Data Review. If you are a clinical professional with the experience mentioned above, please Apply Now! Kelly Clinical Research specializes in delivering clinical research workforce solutions to the world?s leading pharmaceutical, medical device, and biotechnology companies, as well as contract research and site management organizations. We provide contract, temp-to-hire and direct hire opportunities. Areas we specialize in include Clinical Research Associates (In-house and Field-based), Data Management, U.S. and International Regulatory Affairs, Biostatistics and Analysis, Medical Writing, Project Management, GCP Audit and Quality Assurance, Clinical Operations and Support. Kelly Services, Inc. is an Equal Opportunity Employer