Job Description

• The Clinical Data Manager actively participates in all aspects of the data management process from the development of project documentation, system set-up, User Acceptance Testing (UAT), and routine data review through database lock of clinical trials.
• The CDM has a broad, fundamental knowledge of the data management process and can plan, manage, and coordinate activities for assigned tasks with minimal guidance.
• This person may have project level oversight as a study Lead Data Manager.
• The core duties and responsibilities of the CDM are delineated below.
• Manages data management duties to meet study timelines.
• Review and may distribute/coordinate data management metrics, listings, and reports.
• Performs scheduled and ad hoc data listing review and generates/resolves queries in EDC.
• Performs external data reconciliation against EDC.
• Performs Serious AE reconciliation according to SOPs and guidelines, as applicable.
• Provides DM support to Statisticians and Statistical Programmers in production of clinical trial reports and other deliverables.
• Generates and/or reviews/approves study documents (e.g., Data Management Plans, Case Report Forms, DB build specifications, data transfer specifications, SAE and/or external data reconciliation plans, coding conventions, laboratory data handling plan, study protocols).
• Reviews protocols for appropriate data capture including electronic Case Report Form (eCRF) design and external data vendors' systems.
• Reviews and provide feedback to the clinical team on other study documents e.g., Clinical Monitoring plans and vendor specifications.
• Maintains study DM related documents/files for inspection readiness.
• May oversee data management CRO/service providers including manages and monitors the progress of data management activities with CROs and/or other service providers on assigned studies; build effective relationships with CRO/service provider counterparts.
• May assist with the training of new employees and/or contractors (e.g., clinical data associates and/or junior clinical data managers working on the studies).
• May participate in CRO/vendor selection process for outsourced activities.
• May participate in the development, review and implementation of departmental SOPs, templates, and processes.
• Contributes to a professional working environment through exemplifying Core Values.

• Bachelor's degree.
• At least three (3) years of CDM of Data Management experience in the pharmaceutical, biotechnology, or CRO industry; depth and exposure to DM related tasks considered in lieu of minimum requirement.
• Requires solid knowledge of clinical data management principles, clinical trials process and regulatory requirements.
• Good working knowledge of ICH, FDA, and GCP regulations and guidelines.
• Strong well-rounded technical skills (EDC systems, MS Word, Excel, PowerPoint).
• Experience with web-based Electronic Data Capture (EDC), clinical data management systems and industry wide thesauri, such as MedDRA and WHO Drug.
• Excellent verbal/written and interpersonal skills required for working successfully in a cross-functional team environment.
• Ability to handle multiple project tasks and prioritize effectively.
• Well organized and detail oriented.
• Proven ability to work both independently and in a team setting.

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