My client, a major biopharamceutical company based in the north-west, is seeking a Clinical Data Manager to work at their Manchester facility.
Salary £30,000 - £36,000
DUTIES & RESPONSIBILITIES:
Study Data Manager and back-up data manager responsibility for several ongoing single centre and multi-centre UK and worldwide PI PIII trials as allocated. Suites of studies/countries or drug program responsibility.
Delivering clean and locked databases according to pre-determined priorities and timelines adhering to study Gantt charts and ensuring all relevant functions are kept up-to-date
TECHNICAL:
Designing and building Oracle Clinical/SAS/Excel databases including supporting documentation such as aCRF and Database Specifications
Programming validation procedures and generating validation specification documents
Managing SAEs (co-ordination of SAE reconciliation)
Medical coding within Oracle Clinical using MedDRA and WHODD
Running validation, performing discrepancy management and generation/resolution of DCFs
Managing electronic laboratory data including loading Lab Data into Oracle Clinical
Handling of 3rd party data including histology, PK, profilimetry, genomics etc
Assisting in the generation and maintenance of the GLIB and data dictionaries
Assisting with TMS administration including loading dictionaries
Providing internal and external clients with the end product (AE snapshot, final datasets, dirty data transfer etc) as required on time and to the highest standards
ADMINISTRATION:
Preparation, review and approval of study documentation, e.g. data management plan, annotated CRF, manual checks documentation, data entry guidelines etc.
Writing and reviewing data management specific SOPs
Producing accurate and useful data management presentations e.g. for use at Investigator meetings
GENERAL :
Input into the resource/workload and development of junior staff including data entry and junior data managers
Maintaining overviews on metrics and deadlines for studies assigned
Attendance at and, as applicable, running of meetings within data management, across the company or with external vendors/CROs e.g. study team meetings, Investigator meetings
Liasing efficiently and appropriately with external CROs and vendors
Assist in scheduling and co-ordinating data management work to meet required deadlines, ensuring that studies are completed in a timely and efficient manner.
Provide feedback and guidance for members of the department in data management methods and procedures
AS APPLICABLE:
CRF Design including maintaining CRF library pages, chairing CRF Review meetings and liasing with external CRF Printing companies.
Training/mentoring of junior staff in Oracle Clinical, data management and CRF Design procedures
Safety Data processing including all co-ordination and liaison with pharmacovigilance
PRIOR EXPERIENCE & PERSONAL TRAITS:
Essential Experience, Qualifications, Attributes:
Minimum of 1-2 years experience of advanced clinical data management processes
Extensive data management experience in complex Oracle Clinical procedures
Data management SAS programming experience e.g. writing transfer programs
Prior experience of data management in phases I III Clinical Trials
Experience in the coordination of projects with internal and external resources
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