Senior Manager, Data Management
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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.
- 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.