Location: Germany or UK
Closing Date: 08 Jan 17
Salary (£): On Application
We are currently looking to recruit experienced SDTM Specialist / Senior SDTM Specialist for our Clinical Analytics group. We can consider applicants in the UK or Germany (flexible locations, office or homebased). For the right experience we may consider other EU locations.
We are currently looking to recruit an expert in SDTM standards, to work as a Senior SDTM Specialist for our Clinical Analytics group.
We can consider applicants in the UK, Germany, Netherlands, Belgium, France (flexible locations, office or homebased). We may consider other EU locations.
Chiltern is a global contract research organization. We are the leading mid-sized provider of clinical solutions in a variety of specialty areas and engagement models for biopharmaceutical and medical device industries. We operate out of 47 different countries, have managed over 1800 studies and have just over 4200 staff.
We are looking for like-minded people looking for a role designed for career success. The successful candidate will have strong experience with SDTM, and have the ability to implement, maintain and ensure strict compliance with CDISC standards or client-specific SDTM standards.
• Act as SDTM Subject Matter Expert (SME) for both internal and external teams.
• Create CDISC compliant and/or client standard SDTM programming specifications.
• Review SDTM programming specifications for content and compliance with CDISC and/or client standards.
• Review SDTM data domains for content and compliance with CDISC and/or client standards.
• Run and review OpenCDISC reports.
• Create and review SDTM compliant annotated CRFs (aCRF).
• Create and review SDTM CRT packages (define.xlm and reviewers guide).
• Participate in the development and refinement of SDTM processes and create standards as needed.
• Interaction with other departments, training of staff and other departmental administrative duties.
• Serve as contact with clients for SDTM aspects of clinical studies.
• Maintain familiarity with the protocol, CRF, and data structure.
• Represents Biometrics department on interdepartmental project teams.
• Perform other duties as required by the Department
• Computer science/math degree or equivalent.
• Relevant experience successfully perform the key responsibilities of the job
• Clinical trial experience in working with SDTM standards. Knowledge of SDTM-IG v3.1.1, v3.1.2, v3.1.3
• Previous experience working extensively with Biometrics project teams
• Strong communication skills, both written and oral.
• Excellent interpersonal skills
• High degree of accuracy and attention to detail
• General understand of ADaM Standards
• Strong organizational skills
We can offer competitive salaries, benefits that are designed around you, a strong support mechanism and dedicated coaching to develop your career.
This is a Full Time permanent opportunity.
About the department: Clinical Analytics is a unique and well established business unit within Chilterns’ Strategic Staffing Provision that provides Biostatistics, Data Management and Statistical Programming solutions to some of the largest Pharmaceutical companies globally.
As part of these diverse partnering models we can offer all the benefits of working for a dedicated CRO whilst gaining exposure to the Pharmaceutical sector. Chiltern is also a dedicated partner and leader in CDISC standards and compliance. We offer a great place to learn and develop strong CDISC skills and the goal of our team is to develop global CDISC leaders.
• For a confidential discussion about this opportunity, please phone + 44 (0) 1753 216639
• To apply, please send your CV to Hannah.King@Chiltern.com
• Please note that if your experience does not mirror that of our requirements for this role you may not receive a response
• No agency submissions will be considered
171 Bath Road Slough Berkshire
SL1 4AA, UK
|Tel:||+44 (0) 1753 512000|
|Fax:||+44 (0) 1753 511116|
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