Records Specialist

• The Records Manager (RM) is responsible for the oversight of Clinical Documentation activities relating to the management of the study TMFs.

• The RM is a member of the Clinical Team and is responsible for the following activities for their trials:

• Supervises the study TMF set-up in the eTMF/EDMS system and develops any trial-specific instructions/documentation for the Clinical Documentation Team. 

• Provides support and direction to the Clinical Documentation Coordinators, Clinical Documentation Administrators and Clinical Documentation partner CROs in the processing of the TMF documents in order to ensure TMF Document Quality (document legibility, minimum content check), proper indexing /filing (both paper and electronic) and real-time management of documents submitted to the TMF. Acts as a back-up for Clinical Documentation Coordinators.

• Monitors the completeness and quality of the TMF. He/she provides metrics and TMF progress reports to the Clinical Team.

• Provides support and expertise to the Clinical Trial Team members on the TMF Management Processes and the eTMF/EDMS system. He/she is the contact within the Clinical Team for any TMF related.

• Reports study TMF progress or any issue to the Clinical Team, the Regional Manager, and Records Manager in charge of the program

Skills:  

• Very good knowledge of the clinical development process: at least 1 year experience in clinical research

• Formal training in GCP methods

• Very Good knowledge of the TMF regulations, ICH, etc.

• Knowledge of Code of Federal Regulations (US) and regulatory agency documents

• Ideally previous experience as a Records Manager or Clinical Research Associate.

• Fluent English communication skills, verbal and written

• Very good interpersonal skills - ability to work with individuals at different levels

Education:

Bachelors’ Degree or equivalent qualification/experience

For More information, Contact:

Sneha Shrivastava

973-967-3348

sneha.shrivastava(at)artechinfo.com