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1M
1000 Merck Sharp & Dohme LLC
Associate Director, Clinical Data Management
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What they do
A Data Manager manages databases and coordinates data collection and analysis for a company or organization. Develops procedures for documentation and data storage. Performs or manages data analysis for studies, projects and reports.
$152,664 / year median in New Jersey
+10% projected growth
Job Description
Job Description The Principal Trial Manager is responsible for leading projects and initiatives to improve the quality and compliance of the data management functional areas in addition to the regular responsibilities as an individual Trial Manager. The Principal Trial Manager is responsible and accountable for the successful execution of the clinical data management strategy for one or more drug or vaccine trials within the TM role. Will be responsible for leading and/or representing data management functional areas or GDMS in cross-functional initiatives and project teams as deemed appropriate. Principle Trial Managers will possess end-to-end data management knowledge with strong project management and leadership skills which are transferable from pipeline to process to special initiatives.
Will interact with Trial Managers as SME, Mentor and Trainer within areas of expertise and provide project leadership to help develop knowledge within the department and will be able to work independently or as a team member or leader with equal effectiveness. Primary activities include, but are not limited to: Lead Special Projects and Initiatives within GDMS. Act as a SME, mentor, and trainer on data management, project management, leadership and other areas of expertise. Support Training & Development programs to promote Trial Manager end-to-end proficiency. Support and provide input to the functional process owners (PO)/ potentially serving as an SME to support process implementation. Partner with functional area representatives to assess and promote consistency in the use of database standards and trial design/peer review support as needed. Identifies, defines and implements improvements to data collection, data and project management processes and tools. Support audits and inspections as necessary. Functional & cross-functional special project management. Complex Risk Management. All required activities outlined in the TM job description. Education/Experience (ex-Us, subject to local requirements): B.A. or B.S. degree, preferably in life sciences, computer science, or related discipline, with at least 6 years' experience in Clinical Data Management or a mix between Data Management and Clinical Research and at least 3 years' experience working with formal project management tools and processes.
Will interact with Trial Managers as SME, Mentor and Trainer within areas of expertise and provide project leadership to help develop knowledge within the department and will be able to work independently or as a team member or leader with equal effectiveness. Primary activities include, but are not limited to: Lead Special Projects and Initiatives within GDMS. Act as a SME, mentor, and trainer on data management, project management, leadership and other areas of expertise. Support Training & Development programs to promote Trial Manager end-to-end proficiency. Support and provide input to the functional process owners (PO)/ potentially serving as an SME to support process implementation. Partner with functional area representatives to assess and promote consistency in the use of database standards and trial design/peer review support as needed. Identifies, defines and implements improvements to data collection, data and project management processes and tools. Support audits and inspections as necessary. Functional & cross-functional special project management. Complex Risk Management. All required activities outlined in the TM job description. Education/Experience (ex-Us, subject to local requirements): B.A. or B.S. degree, preferably in life sciences, computer science, or related discipline, with at least 6 years' experience in Clinical Data Management or a mix between Data Management and Clinical Research and at least 3 years' experience working with formal project management tools and processes.