Job Description

Senior Clinical Data Manager

The Senior Clinical Data Manager (SCDM) handles all project management documentation, clinical data management activities, and system implementations for EDETEK's eClinical, and may be assigned work on other platforms. This includes writing design specifications for the system (forms, reports, etc.) and facilitating testing of system implementations. The SCDM is also responsible for all other traditional clinical data management operations and activities such as facilitating database audits, coding, SAE reconciliation, system and module testing, data cleaning, and locking and unlocking of clinical databases. The SCDM is responsible for translating the client's Clinical Data Management requirements and expectation into the DMP and implementing the clinical data management plans so that the clients expectations are met. The SCDM is responsible for the quality and integrity of the data in the final locked clinical database.

Ensure other Data Managers are trained and oversee the quality of all database start up standard essential documents and activities. Manage the work of outsourcing vendor and will approve the following key standard study documents: CCGs, Database clean plan, check validations, User Acceptance plans, eCRF development and DB lock plans.

The SCDM should thoroughly understand the requirements for Good Clinical Data Management services, including its documentation; be willing to be involved in start-up or wrap-up of in-house and client-specific data management projects; have an understanding of the relevant therapeutic indications, study hypotheses, and trial design; and have a solid understanding of database design and structure.

Essential Functions and Responsibilities

• Support Internal Clinical Data Management Initiatives
• Complete Traditional and Assigned Data Management Operations/Activities
• Contribute to Project Success by Conducting Duties per CPM/LSCDM Request
• Design Case Report Forms (CRFs)
• Assist in the Development and Maintenance of Systems Used to Support Project Infrastructure
• Work with Clinical Data Specialists (CDSs) to Execute Data Management Plans
• Work with Clients/Sponsors as Necessary to Deliver Contracted Clinical Data Management Services and Clinical Data with High Quality and Integrity
• Code Data per Selected Coding Dictionaries
• Clean Data
• Develop / Execute Testing Strategies
• Assist with Data Transfers, Loading and Integration
• Complete All Required Documentation per EDETEK and Project Requirements
• Perform Use Acceptance Testing (UAT) on New Software
• Classify Clinical Events per Agreed-upon Strategies/Plans Classification

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