Company: Key People Limited
Closing Date: 15 Dec 16
Type: Full Time
Salary (£): 40,000 - 60,000
Benefits: 10% Bonus (of salary)
My client is looking for a candidate to oversee clinical data management practices and to develop data management strategies. The candidate will oversee and participate in clinical data management activities, including: Case Report Form (CRF) design, CRF completion guidelines, database design specifications, data management plans, edit check specifications, serious adverse event reconciliation, medical coding, electronic data transfer agreements, data review and database lock.
· Provide leadership in the design, planning, execution, collection and handling of clinical data to quality standards, internal SOPs, ICH guidelines, GCP, and regulatory requirements.
· Develop resourcing strategies for the data management team
· Oversee clinical data management practices to assure standardization across clinical programs
· Mentor and manage clinical data managers and data coordinators.
· Act as lead clinical data manager for clinical studies in collaboration with multidisciplinary project teams
· Manage timelines for key clinical data management deliverables in coordination with vendors and cross-functional project teams to drive data management project delivery
· Lead and coordinate the evaluation and selection of vendors, e.g. Contract Research Organizations (CROs), software, e.g., EDC or IRT, for outsourced clinical data management activities.
· Oversee and participate in clinical data management activities, including: Case Report Form (CRF) design, CRF completion guidelines, database design specifications, user acceptance testing, data entry guidelines, data management plans, edit check specifications, serious adverse event reconciliation, medical coding, electronic data transfer agreements, data review and database lock.
· Develop or update clinical data management working practices and Standard Operating Procedures (SOPs).
· Ensure compliance of clinical data management processes with applicable regulations and guidelines.
· Ensure that all interactions and engagements are carried out with the highest ethical and professional standards and that all work is accomplished with the upmost qulity.
Education and experience
· Bachelor’s degree, or educational equivalence
· Significant experience in clinical data management across Phase 1-4 clinical trials, including prior management experience. Registry experience is a plus.
· Sound knowledge of clinical data management processes and comprehensive experience with electronic data capture systems. Familiarity with IRT systems, lab data systems, and other third party software.
· Ability to compare and evaluate third party data management systems.
· Experience managing data management activities and vendors from project initiation through to database lock and closeout.
· Knowledge of and experience in working to regulatory guidelines appropriate to clinical data management, reporting of clinical study data and regulatory data submission standards.
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