Associate Data Manager

The Associate Data Manager will be responsible for assisting Data Managers with day-to-day tasks around documentation, data processing and data reporting to the clients.
The Associate Data Manager will also export, clean and review clinical submission files for accuracy and completeness prior to delivery to client.
The Associate Data Manager will evaluate and take action on client reconciliation feedback that is provided to ERT between data transfers as part of the standard reconciliation process.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Perform quality and/or consistency checks on the output file(s) generated by study specific programs where required.  This can include comparing individual data points of the final output data to the corresponding data points of the original dataset based upon the gathered requirements and/or edit check output.  

• Communicate with appropriate Clario staff (i.e. Data Manager, Science teams, medical staff) regarding any discrepancies found and document all results and/or changes.

• Work on study documentation (DMP/DTS) under the guidance of the 

• Data Manager and also assist in getting study documentation prepared for client review.
• Serve as a point of contact for updates needed to the CDM task schedule (i.e. edit checks, transfer scheduling, Final data transfer checklist, etc.) and ensure they are being completed and/or maintained.

• Assist with metrics related to data issues or file delivery as well as ensuring the systems have correct information regarding study assignment.

• Provide assistance to CDM team for documents, presentations, etc. that require template updates and formatting changes.

• Serve as primary recipient of client reconciliation feedback between data transfers and ensure appropriate investigation and/or action on those requests within the agreed turnaround time.

• Ensure good quality documentation is maintained in regard to the client reconciliation feedback.

OTHER DUTIES AND RESPONSIBILITIES:

• Communicate project status clearly with Clients and Project Management.

• Assist with the maintenance and storage of study documentation relative to data management activities.

• Contribute to continuous process improvement including workflow efficiencies and associated workflow documentation.

• Assist in CAPA issues related to study-specific data management activities.

QUALIFICATIONS AND SKILLS NEEDED:

• BS/BA Degree in Life Sciences or related field

• Minimum of 2 years experience working with clinical data

• Familiarity with clinical data reports, GCP, and general understanding of clinical trials

• Strong organizational, interpersonal, analytical and communication skills

• Detail-oriented

• Experience with Windows and Microsoft Office products preferred

• Ability to communicate effectively in English 

• SAS and/or SQL exposure or experience a plus

• Knowledge of CDISC SDTM is a plus