Associate Data Manager

3 days ago

Noida, India Clario Full time
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.

ESSENTIALDUTIESANDRESPONSIBILITIES:

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.

OTHERDUTIESANDRESPONSIBILITIES:

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.

QUALIFICATIONSANDSKILLSNEEDED:

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

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