Sr. Clinical Research Associate (Project Management Leader)

Job Category:Project Management Leader Primary Location:USA-MD: MARYLAND-FREDERICKSchedule:Full-time Job Type:Regular Employee Status:RegularJob Posting: 01/29/2008Description: Essential Job Functions Assists clinical project manager(s) in the management and coordination of assigned clinical research studies, in compliance with FDA regulations, ICH GCP guidelines, and SOPs. May serve as a liaison with CROs to ensure quality service and clinical study conduct. Evaluates and participates in selection of consultant, CROs, and study sites to conduct clinical research activities. Ensures that the clinical study sites, CROs, and other vendors are in compliance with GCPs and relevant SOPs. Tracks activities associated with clinical trials. Under direction of a clinical project manager, prepares necessary clinical documents and study-related documents, such as assigned portions of a protocol, protocol amendments, informed consent guidelines, assigned portions of investigator brochures, transfer of regulatory obligations (TORO) forms, and study operations manuals. May assist in preparing and reviewing Statements of Work (SOWs) and Requests for Proposals (RFPs). Provides direction to CRO Clinical Research Associates. Has assigned projects. Responsible for updating assigned SOPs pertaining to management of clinical studies and Clinical Research Department activities according to GCP. Participates in the review of Investigator Brochures, study reports, safety reports, statistical tables and data listings, and clinical sections of Annual Reports, INDs, marketing applications (NDAs/BLAs), and briefing documents. Work with internal staff, consultants and medical writers. At least 2 years in-house or field clinical monitoring (CRA) experience. Creates and implements project definitions, schedules, budgets, and objectives for medium to large sized projects of moderate complexity. Prepares statements of work for project engagements and monitors performance to ensure that project commitments meet contractual specifications. Determines need for and impact of changes in scope of project and makes recommendation based on determinations. Gains concurrence, approval, and consensus from stakeholders regarding the various project aspects, adjusts accordingly. Identifies appropriate resources and staffs projects. Organizes project team members to ensure communication and understanding of deadlines, assignments and objectives. Acts as the point of contact with client project management. Manages costs, schedules and quality by overseeing project deliverables. Ensures schedule and budget are met. Identifies need for changes and revises within established guidelines/policies as appropriate. Performs ongoing review of project status; identifies project risks. Develops, recommends and implements risk mitigation solutions as approved and as appropriate. Interfaces with team members and stakeholders to anticipate and manage changes to projects such as but not limited to, technical requirements, business requirements and schedule. Determines when additional resources are need and implements same. Manages mid-level management clients, company management and project team expectations for agreed upon project performance by obtaining and providing project metrics. Develops and makes presentations that could lead to expanded business opportunities. Participates in proposal efforts and sales calls to enhance opportunities for future business deals with client. Oversees assigned personnel for projects. Assigns work and provides direction with regard to timeliness and completion of project objectives. Addresses performance issues within prescribed guidelines. Provides performance input upon completion of project. Basic Qualifications Bachelor's degree or equivalent combination of education and experience Bachelor's degree in business administration, information technology, engineering or related field preferred Six or more years of clinical research and project management experience Experience working with project management methodology such as Catalyst including budget development, project planning, control and assurance methodologies, project management software and finance and accounting concepts and practices Experience working with productivity and methodology tools that increase project efficiency and effectiveness Experience working with administrative processes Other Qualifications Good personal computer and business solutions software skills Strong communication skills Good leadership and organizational skills Good analytical and problem solving skills Good interpersonal and presentation skills for interacting with team members, clients and company management Good human relations and leadership skills to train, guide, motivate and mentor the work of project personnel Basic negotiation skills to participate in new business development opportunities Ability to work in a team environment Ability to deal with ambiguity and change Ability to create and maintain formal and informal networks Willingness to travel Remote Work Location Authorized:No Relocation Assistance:Not AvailableClearance Level:None Create Success