The Data Manager oversees and reviews the day-to-day management of clinical data for global clinical studies. The Data Manager works with the Clinical Project Team on studies and acts as the point of contact for all data management responsibilities. This person is responsible for the design, setup and execution of the Data Management Plan, ensuring that all captured data follow the rules outlined by the protocol(s) and data management plan(s).
- Serves as primary DM contact in assigned studies and ensures that data cleaning is performed in a consistent way between team members
- Oversees the vendors responsible for all Data Management activities, inclusive of a Full-Service Provider and CRO
- Coordinates all tasks within the Data Management process between different team members from database development to database lock
- Prepares or oversees the development of data management plans, data entry guidelines, reports and other documents required for preparing and completing databases
- Supports database development activities and coordinates database amendments in collaboration with the database development team
- Oversees the Data Management Plan inclusive of database lock
- Maintains the Data Management section of the eTMF of assigned studies
- Reviews CRFs, data listings, and databases to ensure all captured data follow the rules outlined by the protocol and data management plan
- Generates queries to appropriate internal or external personnel (investigational sites, vendors, Clinical Research Associates (CRAs), client representatives) to resolve problematic data identified during every aspect of the data management process
- Reviews responses to queries for appropriateness, resolves any discrepancies and modifies the database accordingly
- Responsible for reconciliations of 3rd party data
- Supports the Clinical Project Team and department management in reporting of financial project status, study metrics and performing data management tasks within budget compliance
- Assists in developing a standard set of test data for use in testing data entry screens, data listing presentation, and programmed logical edit checks, as required
- Prepares documentation noting the testing changes and performs follow-up testing to validate that the changes have been made, as required
- All other projects as assigned
- Minimum of five (5) years data management experience, including experience serving as a Lead Data Manager. Alternatively, must have proven experience in all primary job functions
- Understanding and experience with up-to-date MS Windows Operating Systems and applications. Prior experience using computerized information systems preferred
- Knowledge of at least one database management system (e.g., Data Labs, Medidata RAVE, Trial Master, etc.)
- Knowledge of ICH and local regulatory authority drug research and development regulations preferred
- Attentive to details and able to independently resolve a variety of issues without close supervision
- Desire to work in a fast-pace, dynamic environment
- Excellent communication and presentation skills
- Team player
- Ability to read, write, and speak fluent English
- A high degree of autonomy; takes accountability for work
- Very organized and efficient; produces high-quality deliverables
- Working knowledge of FDA Guidance Documents / EU Directives / ISO14155 regulations, drug / device development, and clinical monitoring procedures
- Knowledge of web-based communication tools for conferences
- Working knowledge of medical terminology and experience with clinical research
Minimum of a bachelor’s degree, preferably in a life science.
Relevant professional certifications a plus
Cerevel is an Equal Opportunity Employer and does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other characteristic protected by applicable law.
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