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Job Details

Data Standards Specialist

Company: GCE Solutions
Location: Flexible
Reference: 222
Closing Date: 13 Dec 17
Type: Permanent
Salary (£): Competitive
Benefits:

Job Summary:

The role of a Data Standards Specialist at GCE Solutions is to lead and contribute to Clinical Data Standards planning, definition, development, validation and support within assigned standards discipline (domain) including the development and maintenance of associated metadata, documents, business rules and guidelines where applicable.

Requirements:

Responsibilities:

  • Serves as the primary contact for global data acquisition and tabulation standards for core global and/or assigned high complexity Therapeutic Area ensuring timely and quality deliverables.
  • Define and deliver to robust, priority driven standards development plans for assigned area to ensure agreed deliverables are met.
  • Accountable for driving the efficient, high quality and timely implementation of new standards and/or updates to standards for:
  • Data Acquisition and Tabulation standards
  • Standards in clinical systems including EDC, MDR and other global standards libraries including robust testing and validation
  • Compliant data models to support the use and transformation of data acquisition, tabulation and review standards (including associated metadata).
  • Processes, tools and guidelines relating to the submission of standardized acquisition/tabulation data supporting regulatory submission.
  • In collaboration with representatives across Data Operations disciplines and key stakeholder and partner functions within GDO and across Global Drug Development, lead the accurate translation of scientific and analytical requirements into efficient, compliant standards.
  • Support and ensure the appropriate and efficient governance and approval of global and project/study specific clinical data standards liaising with governance boards as needed.
  • Lead the technical review and assessment of industry and regulatory standards and guidelines supporting regular gap/impact analysis and implementation of action plans where needed.
  • Communicate effectively with the partners and customers; Establish and maintain strong collaborative relationships with Data Operations, Biostatistics and Clinical Development groups supporting the development and use of Clinical Data Standards. 
  • Lead and contribute to the development, maintenance and training of relevant clinical standards systems and processes as required.
  • Act as an expert consultant providing Clinical Data Standards input to all relevant areas including; electronic data capture, edit checks, report programming, electronic data loads, IVR, electronic patient reported outcomes, metadata management etc
  • Act as primary subject matter expert (SME) for assigned area providing support, consultation and training to end users and SME networks on implementation of standards and related tools on development programs.
  • Provide mentoring and technical guidance to Clinical Data Standards associates
  • Maintain up-to-date, advanced knowledge of relevant technologies (EDC, software languages, applications etc.), Industry Standards (e.g. CDISC, define.xml, eCTD etc.) and regulatory guidelines.
  • Represent company within industry wide associations and working groups; contributing to regulatory guidelines, industry practices and professional standards development organizations such as CDISC, CFAST, PhUSE CSS, DIA etc.
  • As needed, act as a Clinical Standards representative leading and supporting data standards governance, process improvement initiatives and/or other non-clinical projects.

GCE Solutions is a global clinical research organization (CRO), founded in 2006 in the US. We assist in clinical development in the pharmaceutical, biotechnology, and medical device industries with various programming, statistical, and consultancy tasks among an array of therapeutic areas and phases. We have offices in the US, Europe and India.

Every employee has a personal development and career plan, and due to the growth of the company, the development potential is huge. We also offer an annual performance bonus, and a competitive benefits package. 

Apply for this job: Data Standards Specialist

Contact Information:

Address:  UK
82 King Street, Manchester
M2 4WQ
England
Tel:  0044 208 432 2994
Website:  Visit Our Web Site

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