Closing Date: 17 Feb 17
Salary (£): Competitive
Benefits: on application
Project Data Manager/Senior Project Data Manager role within Project Data Services. Office or home based working.
Chiltern: 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 currently looking to recruit experienced Project Data Managers for our Biometrics group. Candidates with significant prior experience and a proven track record in delivering on projects will be considered for the Senior Project Data Manager role.
We are looking for like-minded people that want a job designed for career success. Experience in any of the following Data Systems would be beneficial.
• Medidata Rave®
• MedNet, iMedNet™
• Merge eClinicalOS®
• Oracle® InForm
• Perceptive DataLabs®
We can offer competitive salaries, benefits that are designed around you and a strong support mechanism and dedicated coaching to develop your career within Data Management.
This is a full time permanent opportunity.
• Support clients’ business objectives by ensuring the accurate and timely acquisition of diverse clinical data through efficient CRF/eCRF design, edit specifications, and query resolution processes
• Serves as a Data Management Lead for one or more complex studies
• Works collaboratively with Programming (Clinical and Statistical), Clinical Operations, Biostatistics and other internal teams.
• Develop and implement project plans for relevant Data Management projects.
• Create project specific Data Management Plans (DMPs)
• Provide input, assistance and/or oversight with preparation of edit check specifications for a specific project, Data entry guidelines preparation, Case Report Form design and associated specification
• Delegate tasks to CDA I and CDA II staff members
• Provide technical and business process input/expertise
• Assist with and/or oversee the creation of test data for entry screens and edit checks
• Serve as primary contact for DM with all relevant parties including but not limited to Clinical Operations and Sponsor, informing stakeholders if there is a need to deviate from project scope or plan
• Participate/attend Sponsor requested meetings as required
• Participate in and/or contribute to Sponsor and/or Regulatory audits/inspections
• Life Sciences degree or Nursing qualification
• Ability to maintain confidentiality of data and information during interactions with staff at all levels
• Prior experience in Data Management in the pharmaceutical, biotechnology, medical device/diagnostics or clinical trial industries.
• Effective communication skills
• Working experience with Medidata Rave, Inform and Oracle Clinical is preferred
• Strong leadership qualities and experience of supervising other Data Managers
• Hands on experience with EDC systems
• Good knowledge of the drug development life cycle
• 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
• 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
• 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
37 bis rue de Villiers, 92200 Neuilly sur Seine, France
|Tel:||+33 1 41 05 73 00|
|Fax:||+33 1 41 05 73 01|
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