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Expert Clinical Data Manager Location: US-NJ-Whippany Email this job to a friend
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Tekwissen Group, is a workforce management provider throughout the USA and many other countries in the world. This client is a German multinational Pharmaceutical and biotechnology company and one of the largest pharmaceutical companies in the world, headquartered in Leverkusen, and areas of business include pharmaceuticals; consumer healthcare products, agricultural chemicals, seeds and biotechnology products. Job Title: Expert Clinical Data Manager Location: Whippany, NJ, 07981 DEPARTMENT/TEAM DESCRIPTION -
The Contract Expert Data Manager leads the execution of data management activities necessary for the preparation of submission data and required documentation for regulatory authorities. -
They are proficient in at least one area related to clinical data management, so they may be considered subject matter expert on the respective topic. -
The Contract Expert Data Manager may assume the business role of a Study Data Manager (SDM) in several studies and PDM role. -
The successful candidate can drive innovation and solve complex problems with a customer-focused mindset. -
They are a self-starter who can see the big picture, contribute and execute DM strategies and special projects under the guidance of the Director and Sr Director of Data Generation Management and Quality. -
To excel in this role, the candidate will balance competing demands and prioritize effectively. They need to possess the skills and knowledge necessary to maintain high data quality. POSITION DUTIES & RESPONSIBILITIES -
Serves as the key subject matter expert on topics related to data management -
Must be able to answer questions about SDTM, handle SAS and XPT files, perform basic SAS filtering, and run macros. Ability to explain the data flow process to team members -
Able to create complex reports from raw dataset, and be able to use reporting tools (e.g., MS excel, J-review, knowledge of programming tools such as SAS or R preferred) -
Some experience with RWE, IIR, and collaborative studies is highly desirable. -
Supports developing and implementing Project and Study Data Management strategic initiatives and activities to improve and optimize the delivery of Project and Study Data Management and data quality metrics -
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