Senior Manager, Data Management

Proclinical are recruiting for a Senior Manager, Data Management to join a CRO. This role is on a permanent basis with the ability to work remotely from the UK or EU.

Responsibilities:

• Accountable for the execution, method, and configuration of metadata used to handle libraries of CDISC linked metadata, vocabulary and linked standards.
• Handle clinical standards experts.
• Outline and execute core company, sponsor and therapeutic area standards for the purpose of increasing effectiveness, productivity, and quality of deliverables of SDTM, CDISC standards.
• Offer data standards knowledge to study teams to guarantee effective compliance with data standards and regulatory proposal needs.
• You will use influence and ability to efficiently form relations across the international corporation in assistance of the standards vision and discuss development actions and standards metrics.
• Other duties may be assigned.

Key Skills and Requirements:

• Educated to a degree level in a life science or analytical field.
• Pertinent work experience.
• Handle direct reports or guided project teams within a matrix setting.
• A background in development and management of a standards library.
• Know-how of data management systems and procedures, analysis and reporting principles.
• Expertise on clinical programming features of clinical research, data management, standards compliance strategies, metadata management and data analysis.
• Know-how of all CDISC guidance documents and execution guides, as well as FDA, EMA, and PMDA guidance and regulations concerning electronic proposal of data.
• Communication skills both verbally and in writing with the ability to exhibit leadership skills.
• Works well with others on various tasks.
• Knowledge of various functional area standards or various CDISC standards.
• Capable of planning, monitoring, executing and supervising standards governance procedures.
• Able to engage with clients in library management of client-specific standards, business development and consultancy with both internal and external clients.
• Computer literacy.

If you are having difficulty in applying or if you have any questions, please contact Matt Childs on +44 203 967 1000.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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