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

Thanks

Regards

Ricky