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The Clinical Data Manager (CDM) is responsible for all aspects of the data management process from the development of project documentation, system set-up, UAT through database lock for assigned studies. The core duties and responsibilities of the CDM are delineated below. Essential ...

Job Description

The Clinical Data Manager (CDM) is responsible for all aspects of the data management process from the development of project documentation, system set-up, UAT through database lock for assigned studies. 
The core duties and responsibilities of the CDM are delineated below. 

Essential Duties/ Responsibilities 
Department Level: 
• Participates in the development, review and implementation of departmental SOPs, templates and processes 
• Supports budget and resource planning across assigned projects 
• Contributes to technical infrastructure of data management 
• Participates in CRO/vendor selection process for outsourced activities 
• May participate in department or cross-functional initiatives 

DM/Study Tasks: 

• Represents data management in study team meetings 
• Manages data management timelines to coordinate and synchronize deliverables with the overall study timelines 
• Generates and/or reviews/approves study documents (e.g. Data Management Plans, Case Report Forms, data transfer specifications, SAE and/or external data reconciliation plans, coding conventions, study protocols) 
• Executes and/or distributes data management metrics, listings, and reports, as required 
• Oversight of data management CRO/service providers on assigned studies 
• Monitors the progress of all data management activities on assigned studies to ensure project timelines are met 
• Provides training on the CRF completion guidelines and EDC system at Investigator meetings and to internal or external team members, as needed 
• Proactively identifies potential study issues/risks and recommends/implements solutions 
• Responsible for the accuracy and completeness of the clinical data collected during a clinical trial, able to work independently towards the assigned goal 
• Provide DM support to Statisticians and Statistical Programmers in production of clinical trial reports and other deliverables

Requirements 

• Requires solid knowledge of clinical data management principles, clinical trials process and regulatory requirements 
• Excellent verbal/written and interpersonal skills required for working successfully in a cross- functional team environment 
• Able to communicate and collaborate effectively with cross-functional teams in face-to-face conversation, by telephone, and by email 
• Good working knowledge of ICH, FDA, and GCP regulations and guidelines 
• Strong well-rounded technical skills (EDC systems, MS Word, Excel, PowerPoint) 
• Knowledge of industry standards (CDISC, SDTM, CDASH) 
• Experience with web-based Electronic Data Capture (EDC), clinical data management systems and industry wide thesauri, such as MedDRA and WHO Drug. 
• Proven ability to work both independently or in a team setting 

Education/ Training 
• Bachelor degree in Life Sciences, Computer Sciences, Mathematics, or health-related field 
• Minimum of 5 years of SENIOR-LEVEL DM (i.e., Sr. CDA) experience in the pharmaceutical or biotechnology industry or equivalent; depth and exposure to DM related tasks considered in lieu of minimum requirement 
• CRO management experience desired 
• Competence in SAS programming a plus 
• Prior oncology/hematology experience highly desirable