Clinical Data Manager

 

Specific tasks would include:

• Manage end-to-end delivery of data management services for single/multi-service projects with minimal guidance, ensuring quality deliverables on time and within budget, to customer satisfaction.

• Provide comprehensive data management expertise to Clinical Data Management (CDM) team to provide high quality data management products that meet customer needs.

• Provide leadership to the team in the areas of project planning, execution, and close-out; financial management; communications; and milestone deliverables.

• Perform role of Data Team Lead (DTL). Comply with Good Clinical Practices (GCPs), applicable regulatory guidelines, SOPs, policies, and, where available, CDM guidance documents.

• Serve as primary point of contact for customer on data management deliverables.

• With guidance, provide input for and perform direct negotiations with customer, e.g., timelines, financial, process, resources.

 

Qualifications:

• Bachelor's degree, preferably with a scientific background

• At least 5 years as Clinical Data Manager in the Pharmaceutical industry

• Good knowledge of CDASH and SDTM

• Ability to solve problems and motivate others

• Strong attention to detail

• Commitment to quality and reliability

• Good planning and analytical skills

• Excellent communication skills

• Fluent written and oral English