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 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