Provide operational leadership for assigned trials executing them on time and within budget Overall coordination and management of clinical trials from startup to closeout Liaise with other functional areas to identify issues, evaluate and make sound business decisions and ensure implementation of timely solutions. Identify and select high-quality clinical vendors in conjunction with the appropriate team members Work with the contracting/budgeting team to ensure that vendor responsibilities and payment terms are clearly defined. Manage and effectively provide oversight of assigned clinical vendors and functional service providers to ensure data integrity and adherence with regulatory requirements. Assure that team is receiving high quality, on time deliverables from internal and external vendors. Collaborate with other team members to coordinate the development and finalization of key study documents including protocols, case reports forms, informed consent documents, study management plans and final clinical study reports. Work with finance manager on financial aspects of the project(s), including milestone payments, and monthly pass through invoices Lead or facilitate teleconferences with internal or external group. Assume co-monitoring responsibilities as needed. Communicate with Principle Investigator, Study Co-Coordinator, and/ CRO (if applicable) to proactively recognize problem situations and work with other team members as required to resolve issues
Manage the publication process in conjunction with the publications team to assure that submission timelines are met. Monitor and report clinical trial status using standard and adhoc review & reporting procedures and identify issues that affect functions. Ensure that each function is accountable for their deliverables. In collaboration with Project Management and utilizing various tracking mechanisms, manage clinical trial project milestones and budget. Proactively identify issues and escalate to appropriate managers.
At least 5 years of experience in the management of clinical trials as a study manager, significant knowledge of overall clinical drug development and general clinical research operations in Big Pharma or CRO.
Must have; Ability to manage multiple projects simultaneously with strong organizational and planning skills. Well-developed analytical and problem solving skills. Communicates issues to Director with action plans for resolution. Knowledgeable in all required regulatory and compliance standards and guidelines including ICH-GCP. Experience of phase III and Phase IV as a study manager is required minimum 5 years at this level, global experience Must have experience of set up and close out of phase II/III global clinical trials. Experience of IVRS and eDC (inform ideally) set up is also required Ability to effectively work with teams and promote collaborations. Exceptional interpersonal skills including the ability to influence negotiate and resolve conflicts. Excellent verbal and written communication skills and the ability to interact with all levels of management within the organization and to external business contacts. Experience using the Inform database, PowerPoint and Excel software. Independent judgment and decision making skills with respect to functional responsibilities. Innovative and motivated in optimizing clinical operations processes to meet deliverables. Minimum BS or BA in related field; focusing on biological science or nursing preferred or equivalent. Advanced Degree preferred Experience in the epilepsy therapeutic area preferred, but not required.