Senior Clinical Data Manager
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POST DATE 10/11/2017
END DATE 12/9/2017
JOB DESCRIPTIONJOB BRIEF
This position is responsible for day to day data management functions including: CRF development, data edit specifications and EDC training with team and vendors in support of new drug applications that meet FDA regulations and ICH/GCP guidelines.
DUTIES AND RESPONSIBILITIES:
The following reflects management s definition of essential functions for this job but does not restrict the tasks that may be assigned. Management may assign or reassign duties and responsibilities to this job at any time due to reasonable accommodation or other reasons
* Understands the drug development or clinical trial process and those roles, tasks and activities for which Clinical Data Managers assume responsibility.
* Understands the protocol content and relate protocol to CRF design and ensure design supports data analysis and reporting requirements.
* Identifies critical data elements used for analysis and reporting.
* Develops Data Transfer Agreement(s) (DTAs) between external data vendors and/or core labs.
* Assist in reconciling AE/SAE data in Safety DB and/or other Data Management DB,
* Identifies gaps in protocol detail that are necessary for successful CRF design, database design, data cleaning and evaluation of study results and safety data reporting.
* Presents CRF completion instructions at Investigator Meetings or WEBEX; Responsible for EDC training of CRAs and new team members.
* Oversees development of data management plan (including Data Handling Guidelines) and its implementation
* Conducts user testing of systems and applications per written specifications
* Develop edit specifications
* Code or review coding for adverse event, medication history and concomitant medication data
* Oversee IWRS vendor for applicable studies in the design and testing of system; Ensure integration with EDC system is operational
* Review/develop study materials, including case report form (both electronic and paper), data operation guidelines, medical coding guidelines, data analysis plan, clinical study reports, etc.
* Communicate accurate and timely status updates to project team and management
* Work with site personnel and CRAs to close out queries for timely database lock
* Accurately document programs adhering to regulatory standards and SOPs
* Interact with other departments and consultants and be an effective team player
* Understand and follow SOP s and contribute to the development of data management
* Track data issues for prompt resolution
* Contribute to monthly newsletter regarding data trends
* Bachelor's degree, preferably in a relevant biological or health science field with a minimum of 10 years of applicable research related experience
* Knowledge of cGCP regulatory requirements preferred
* Demonstrated knowledge of Electronic Data Capture systems
US WorldMeds' is an equal opportunity employer. US WorldMeds' does not discriminate in any aspect of its employment opportunities or practices on the basis of race, religion, gender, national origin, age, disability, or any other characteristic protected by law.