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Sr. Clinical Data Manager

Zoll Medical Corporation

SAN JOSE CA 95115

Sr. Clinical Data Manager



Tracking Code


1745-547


Job Description



Project Management:



+ Provide data management / data entry / verification / validation / quality control of data collected for worldwide Clinical Trials consistent with applicable regulations, guidelines and policies


+ Oversee proper collection of data and participate in the development and maintenance of computerized data collection system


+ Understand all relevant data standard including FDA Safety & Innovation Act of 2012 (FDASIA), CDISC / CDASH compliant data standards


+ Manage data cleaning process


+ Participate in study start-up and study conduct


+ Ensure conformance with GCP


+ Lead subordinates by developing, communicating, and building consensus for goals and programs that support division and company objectives


+ Investigate and solve problems that impact work processes and personnel in multiple departments


+ Skillfully develops, nurtures and maintains relationships


+ Able to brief management on trial results or status


+ Evaluate performance and assist in career development planning for subordinates



Study Related Material Development and Review



+ Contribute to case report form development and approval


+ Prepare, review and approve Data Management plans and reports


+ Assist with development of Monitoring Plan


+ Lead EDC development


+ Assist in development and implementation of strategy for data cleaning and in the design of clinical databases


+ Generate data retrieval and complete reports as required



Site/CRO/Investigator Management



+ Lead database related activities between sponsor and Contract Research Organizations (i.e. CROs, core labs)


+ Conduct audits of CROs and other outside vendors as necessary


+ Query data for inconsistencies and communicate with sites for query resolution



Training/Scientific Meetings/Other Duties As Assigned



+ Familiarity with Clinical Data Management industry standards (i.e. CDASH, etc.)


+ Adheres to current Good Clinical Data Management Practices Guidelines (GCDMP)


+ Assist with the training of CRAs, Consultants, and Contract CRAs


+ Participate in the development, review and approval of departmental SOPs


+ Attend relevant scientific/medical meetings as needed


+ Responsible for other duties and projects as assigned



General Departmental Responsibilities



+ Confers with Manager, Data Management, Senior Director, Clinical Affairs and other management staff regularly to review internal progress and external conditions and discuss required changes in goals or objectives resulting from current status and conditions


+ Comply with ZOLL Circulation's quality system requirements as well as any applicable regulatory requirements


+ Maintain up-to-date knowledge of global medical device regulations


+ Interact with equivalent level intra- and inter-organizational management and staff concerning matters of significance to the company




Required Skills




+ Analytical - Ability to analyze complex or diverse information; collects and researches data; uses results, intuition and experience to synthesize product specific direction


+ Design - Generates creative solutions; demonstrates attention to detail


+ Problem Solving - Gathers and analyzes information skillfully; develops alternative solutions; works well in group problem solving situations


+ Oral Communication - Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; responds clearly to questions


+ Written Communication - Writes clearly and informatively; presents numerical data effectively; able to read and interpret medical, scientific and engineering literature


+ Organizational Support - Supports organization's goals and values


+ Adaptability & Dependability - Adapts to changes in the work environment; manages competing demands; changes approach or method to best fit the situation; able to deal with frequent change, delays, or unexpected events. Takes responsibility for own actions; keeps commitments; commits to long hours of work when necessary to reach goals


+ Innovation - Displays original thinking and creativity; meets challenges with resourcefulness; generates suggestions for improving work; develops innovative approaches and ideas


+ Motivation - Sets and achieves challenging goals; demonstrates persistence and overcomes obstacles; measures self against standard of excellence




Required Experience



Education/Experience:



+ Must have relevant experience developing and maintenance of clinical data management programs and databases


+ Minimum 5 years in relevant work


+ BS degree in related area


+ Prior people management and clinical data management experience required




Job Location


San Jose, California, United States


Position Type


Full-Time/Regular


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