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Job Information
Job title

Sr. Clinical Data Manager (#4363987)

Company Makro Technologies, Inc.
Wage Not specified
Location United States, California, Bakersfield
Employment type Contract to Perm
Education High School
Year Experience 4 - 5 Years of Practical Experience
Travel Not Specified
Published on 5/25/2005
Description
Looking for a great career opportunity ? Here it is ***Urgent requirement for one of our Top Direct clients in CA*** Please mention Reference Job ID:ISRCDM in the subject line 1. Organization and coordination of internal and external data management activities supporting clinical trials in one ore more therapeutic area. These responsibilities include supporting and influencing multi-disciplinary Clinical Trial sub-teams to effectively manage information flow, data collection, review and clarification activities according to appropriate regulatory and company and departmental guidelines. 2. Responsible for supporting the documentation, testing, implementation, validation and utilization of systems and processes within the Clinical Data Management area. 3. Implements data management procedures compliant with Regulatory requirements. Ensures the consistent implementation of procedures, data standards and data coding dictionaries across assigned studies within therapeutic areas. Collaborates with internal and external resources (CROs) to ensure consistency of methods, interpretation and approach. 4. Manage Contract Research Organizations (CROs) and service providers' activities for outsourced Clinical Trial services. Coordinate internal resources and activities to facilitate timely collaboration with external vendors. 5. Support the development and training of Clinical Data Management personnel. Contribute to the processes for the standardizing of data collection tools, formats and associated documentation (CRFs, e-CRFs, IVRS, hand-held diaries, etc.). Collaborate with others within the department in the review and evaluation of process improvements based on improved operations, methods, or technology implementation. MINIMUM REQUIREMENTSEducation and Experience Degree and experience in Computer Science, Life Sciences or related fields. Four to Six (4-6) years of relevant pharmaceutical development experience with a Bachelor's degree or equivalent. Two to Four (2-4) years of relevant pharmaceutical development experience with a Master's degree or equivalent. Two to Four (2-4) years of leadership role in a Clinical Data Management environment. Minimum of one (1) year in a project management and leadership position with timeline and budgetary responsibilities. Experience in a medium to large pharmaceutical company or Contract Research Organization setting Project Management experience in a clinical data management environment Experience in the implementation of global standards related to clinical study data management activities (CRF design, data standards, data dictionaries, coding and coding dictionaries, etc.)


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Sr. Clinical Data Manager (#4363987)
This job has expired.