Closing Date: 14 Nov 16
Salary (£): Competitive
Please revert to the job description.
Project Leader Data Management (office or home based)
Fixed-term contract for 6 months
Chiltern is the leading, global mid-sized contract research organization. We listen to client needs to deliver customized clinical development solutions with a team of more than 4,200 working across 47 countries to provide comprehensive, yet flexible and responsive, services. Our specialties include clinical development, Oncology, Devices and Diagnostics, Data, Analytics & Evaluation and Strategic Service Provision.
Due to our continuing growth Chiltern is looking to recruit an experienced Project Leader Data Management with Lead or Project Management experience to join our well established European Biometrics Group (Project Data Services PDS). The PDM will provide guidance and general supervision to the Data Management team for designated projects. He/She will monitor specified tasks to ensure quality and integrity of data and execute various data management functions to assist in the smooth running of Global Clinical Trials.
This is a fast paced and challenging role that offers the opportunity to raise your profile in the industry and broaden your experience.
Applicants must have the relevant educational background and experience within EDC studies in Europe in order to be considered.
Job Primary Functions:
• Serve as Data Management Lead on selected International projects
• Create study specific Data Management Plans (DMPs)
• Provide input and assistance in the production of Case Report Forms (CRFs) design
• Assist and oversee in preparation of data entry guidelines
• Assist and oversee in the creation of test data
• Create, issue and update the database with resolved data queries
• Review project files, reports, listings and other documents for accuracy
• Serve as primary contact for DM with Clinical Operations or Sponsor
• Undertake ad-hoc project management responsibilities
• Act as a knowledge resource to other team members and provide guidance and training when required
• Assist Project Manager with budget management
• Life Sciences degree or Nursing qualification
• Extensive experience within Clinical Data Management in the EU
• Working experience with Medidata Rave, Inform and Oracle Clinical is preferred
• Strong leadership qualities and experience of supervising other Data Managers
• Experience in assisting Business Development to create Budgets, Proposals and Bid Defence
• Experience of liaising with clients and meeting agreed level of service
• Hands on experience with EDC systems
• Good knowledge of the drug development life cycle
• Work experience within Data Management for a CRO
• Understanding of the principles of ICH GCP and regulatory requirements
• Good computer literacy with working knowledge of Windows and Microsoft Office applications
• Good oral and written communication, organisational skills and personal presentation
• The ability to communicate effectively in English and German is mandatory (written & verbal)
• Experience working within a team environment under time and resource pressures
• Proven experience in clinical trials with knowledge of SOPs, regulatory reporting requirements and accepted practices
• Confident dealing with external and internal clients and providers
• Fixed-term contract for 6 months
• Home based or alternatively and ideally, we also offer this role as office based at our office in Bad Homburg, Germany
• Applicants must have the relevant educational background and experience within EDC studies in Europe in order to be considered.
• No freelance applications or agency enquiries will be considered
• Please submit your CV and a detailed covering letter explaining why you are suitable candidate. If you do not submit a covering letter this may affect your application
Please send your CV to email@example.com
For more information about Chiltern International, please visit our web site at www.chiltern.com
Successful candidates will have the opportunity to be part of a growing company with a strong brand and professional employees that care about the work they are involved in. Chiltern is constantly working to develop training capacity, therapeutic expertise, new technologies and processes to be one of the leading CROs globally.
Working for Chiltern will offer an excellent opportunity to raise your profile and develop your career whilst giving you the flexibility to enjoy a good work life balance.
Please note that if your experience does not mirror that of our requirements for this role you may not receive a response.
Norsk-Data-Strasse 1, 61352 Bad Homburg v.d.H. Germany
|Tel:||+49 6172 9443 0|
|Fax:||+49 6172 9443 300|
|Website:||Visit Our Web Site|
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