Clinical Project Manager - CNS - Neurology

Schering-Plough is an innovation-driven, science-centered global health care company. Through our own biopharmaceutical research and collaborations with partners, we create therapies that help save and improve lives around the world. We apply our research-and-development platform to human prescription and consumer products as well as to animal health products. Schering-Plough's vision is to "Earn Trust, Every Day" with the doctors, patients, customers and other stakeholders served by our colleagues around the world. Clinical Project Manager - CNS - Neurology Requisition Number: 22550BR The Clinical Project Manager (CPM) in Global Clinical Trial Management (GCTM) will function as a Study Team Leader by organizing and managing all operational aspects of the study from conception to submission while ensuring adherence to timelines. The CPM will also proactively address risk management through contingency planning. The CPM will manage critical study issues such as vendor contracting, budgeting, and drug supply. Major activities will include but are not limited to the following:  Coordinate with all relevant groups to develop clinical protocol timelines. Contribute to building and managing protocol level budgets. Participate in development of operational plans for a clinical study or multiple clinical studies within a development program. Manage the progress of project(s) and ensure adherence to intended timelines including enrollment, clinical supplies, and data delivery, as well as Clinical Study Report (CSR) authoring and review. Oversee study reporting which will be used in both internal and external communications. Identify issues that may impact the overall project plan and initiate contingency plans as appropriate. Knowledge of GCP, ICH guidelines and regulatory requirements for clinical trial management. Work with Regulatory Affairs, vendors and Country Operations to establish appropriate study processes to ensure compliance with guidance and regulations. Act as primary contact with vendors, including review of invoices, preparation and management of scope of work. Review resource requirements and may supervise direct reports. May perform co-monitoring as necessary. QualificationsREQUIREMENTS:· BA/BS; Life Science degree or BSN preferred· Overall 8-9 years experience required in a related field. Minimum 6 years experience in pharmaceutical clinical research.· CNS experience in neurology is strongly desired.· Protocol execution experience required.· Site monitoring experience and management experience preferred.· The CPM needs to be proficient in the areas of Clinical Trial Planning, Execution & Management, Drug Development Knowledge, Scientific Knowledge and Technical Communication. · Knowledge of GCP, ICH guidelines and regulatory requirements for clinical trial management.· Travel is required for this position.Schering-Plough is an equal opportunity employer. M/F/D/V