Clinical Data Manager

About the Organization My company shares my passion for helping to improve human health around the world." "This is My MedImmune." Those who join MedImmune feel a sense of ownership about their future. They thrive with a recognized leader in the biotechnology industry and the wholly-owned subsidiary of AstraZeneca plc. Here, you will join passionate professionals who advance science, technology and medicine to develop products designed to help people live better lives. You will excel in an environment characterized by respect, integrity and growth opportunities• that encourages both individual contribution and collaborative entrepreneurial thinking. Our products and/or product candidates are designed to address areas of need in infection, oncology, respiratory disease and inflammation, cardiovascular/gastrointestinal disease and neuroscience. Explore a MedImmune career as we strive to better more lives, more often, around the world. Description Title: Clinical Data Manager Location: CA, Mountain View - NON SALES Req: 02074 Position Summary: This position is responsible for the oversight of the Data Management function within the Clinical Sample and Data Management group. The department resides within the Research Translational Sciences group and the groups operations support MedImmunes Clinical Development Programs. Major Duties and Responsibilities (including supervising others): ? Responsible for the planning, organization and coordination of all internal and external data management activities supporting research samples for pre-clinical and clinical trials including: ? Leading and influencing team to effectively manage information flow, data collection, review and clarification activities according to appropriate regulatory, organization and departmental guidelines ? Responsible for supporting the design, documentation, testing, validation and utilization of system and processes within the data management area. ? Coordinate internal resources and activities to facilitate timely collaboration with internal and external clients. ? Support the development and training of data management staff. ? Collaborate with Senior Staff in the review and evaluation of process improvements. ? Contribute to the standardization of data collection tools, formats and associated documentation. ? Monitor data management procedures for regulatory compliance. Position Requirements Special Skills/Abilities: ? Excellent interpersonal, oral and written communication skills, including presentation skills ? Strong ability to communicate clearly and concisely ? Builds positive collaborative relationships with a variety of internal MedImmune staff and outside contacts. ? Ability to independently prioritize workload with a sense of urgency in completing work assignments ? Proven ability to move projects to completion ? Proven, sustained record of high-quality independent work ? Proven ability to identify, manage and mitigate risk ? Ability to define problems, collect data, establish facts, and draw valid conclusions Job Complexity: Ability to work independently and collaboratively with sound judgment in cross functional teams. Position and management of systems is complex and errors in judgment would have a serious impact on the organization. Supervision: Proven ability to independently work with network of team members at different locations. Able to effectively lead and develop staff. Reports to Associate Director of CS&DM Educational Requirements Requirements/Qualifications: Education: Bachelors or Masters: Biotechnology; Life Sciences; Computer Sciences or related fields Experience: ? Minimum of 7 years in a related setting (clinical, data management or laboratory) with Bachelors, 5 years with Masters. ? Experience with relational databases, knowledge of the Clinical Trials process and GxP, knowledge of Medical Terminology. Ability to query database for reporting purposes. ? Prior management experience preferred. ? CCDM preferred ? Experience with Microsoft based applications Company Info None Specified

Please refer to job code 02074 when responding to this ad.

Category:	Biotech/Pharmaceutical
	> Clinical Data Management
Location:	Gaithersburg, MD
County:	Montgomery County
ZIP Code:	20877
Pay Rate:	Open
Job Terms:	full time
Company:	MedImmune Inc.
Phone:	email only please
Fax:	email only please