Clinical Data Manager II

Clinical Data Manager II

This is a professional individual contributor role that provides oversight and accountability for more than one low to moderate complexity trial or one high complexity trial.

May be a member of more than one project of low to moderate complexity or member of one project of high complexity.

This position makes recommendations and influences decisions for specific trials or assignments.

The Senior GDM influences processes, timing, and structure for specific trials or assignments.

This position analyzes, provides recommendations, and makes decisions with direction from manager or DML.

This position requires in-depth knowledge of the protocol.

In-depth knowledge of current clinical drug development processes is needed. In-depth knowledge of applicable international guidelines regarding data management of clinical trials is required.

This position needs to understand relevant system/technical knowledge.

Knowledge of technology platforms, confidentiality for data exchange, and project management and techniques is required.

Supervision Received:

Work is received in broad terms.

Work is reviewed during major deliverables.

Amount of instruction is limited.

Work is reviewed with the Data Manager Leaders as well as with the immediate manager.

Supervision Given:

There are no direct reports for this position.

This position collaborates with Vendors/CROs to achieve successful, cooperative partnerships.

This position may delegate tasks and assignments to Global Data Managers.

The Senior GDM recognizes opportunities and contributes to solutions to strengthen the vendor/CRO relationship.

BS/MS in science related field with relevant experience.

Experience with CDMS/EDMS system.

Working knowledge of contract and budget preparation and negotiations.

In-depth knowledge of current industry standards (i.e., CDISC, SDTM, CDASH, etc.) is required.