Reference: PW 6627
Closing Date: 23 Dec 16
Salary (£): Competitive
Leading global pharmaceutical company
· Overseeing clinical disclosure activities involves ensuring company’s disclosure and transparency procedures are maintained in line with evolving regulations; supervision and support of vendor and staff in other departments responsible for disclosure activities; and reporting on compliance status to senior staff.
· Supporting clinical transparency tasks performed by other departments involves providing regulatory input into other departments’ activities and coordinating disclosure activities with other transparency activities to ensure appropriate timing and consistency.
· The role will support the establishment of a new team to achieve these goals.
· Supporting initiatives for the improvement of data management within the company
· Additionally, the role will support the head of the team in other areas within the department’s remit.
QUALIFICATIONS / EXPERIENCE REQUIRED:
· This would suit a candidate with a background in pharma clinical research/operations and working experience of clinical transparency rules and clinical trials disclosure operations
· Education to B.Sc. level or equivalent
· Good knowledge of clinical transparency rules
· Experience with study registration and disclosure on clinicaltrials.gov
· Track record of driving and successfully completing time-sensitive projects across multiple departments and working with key stakeholders
Before you apply for this position it is vital that you are in possession of an EU or UK passport or relevant visa to work without restrictions in the UK.
For a confidential discussion please telephone Anette Gillan at AXESS Limited on 020 8560 2300. To apply, please send your CV to email@example.com quoting reference PW 6627
Study Data Manager, data management, study data management, Clinical Data Management, FDAAA801, EudraCT, EMA Policy 70, PhRMA/EFPIA, clinical operations, clinical, clinical research, Data Quality, clinical transparency rules, clinical transparency data, disclosure procedures, disclosure, disclosure rules, transparency rules, regulatory affairs, regulatory, data standards, disclosure compliance
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