Director, Clinical Data Managment

Description of Position and Responsibilities:Oversees effective project management in Clinical Data Management. Ensures the timely processing and accuracy of clinical trial data that support product development objectives for both investigational and marketed products.Assesses operational needs and requirements to meet department objectives; ensures efficient allocation of resources and adequate staffing to meet study milestones and stay within budget.Provides outsourcing decisions on data management activities. Conducts vendor assessments and performance evaluations. Directs the development of guidelines and specifications for vendor contracts. Manages the development and maintenance of SOPs and WPDs for Clinical Data Management according to Good Clinical Practice (GCP) that meets the requirement of regulations and guidelines. Contributes to the development of other clinical SOPs that are relevant to CDM. Collaborates and coordinates with other clinical operations functional area heads to promote an efficient and seamless clinical trial data flow. Contributes to the development and utilization of standards in data collection, storage and review. Monitors industry standards development and provide advice on adoption strategy. Represents Clinical Data Management in the evaluation, integration, and implementation of new clinical systems and technologies. Establishes system training requirements for CDM staff to ensure understanding, quality output and productivity.Provides mentoring and training to Clinical Data Management staff; prepares performance evaluation and personnel development assessment. Qualifications:Requires a B.S. / M.S. degree with 10 - 15+ years clinical data management experience or equivalent clinical data management experience. Requires advanced knowledge of clinical trial processes and working knowledge of database management methodologies. Is knowledgeable regarding regulations and good clinical practices. Requires >5 years proven management experience in clinical data management. Requires excellent written and oral communication skills, exceptional interpersonal skills and proven team building techniques. Is highly organized and demonstrates close attention to detail. Requires a superior knowledge of medical terminology. Provides solutions to a wide range of difficult and complex process issues. Experience with establishing, evaluating and approving SOPs, Work Practices and data flow processes. The position requires minimal supervision.  MedImmune, Inc. is an Equal Opportunity Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, veteran status, or any other characteristic protected by federal, state or local law. Job Title: Director, Clinical Data Managment Company:  MedImmune Inc. Location:  Gaithersburg, MD 20878 Status:  Full Time, Employee Job Category:  Biotech/R&D/Science Company: MedImmune Inc.