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Job Details

PW 6627 Manager, Data Quality and Standards (Clinical Trials Disclosure)

Company: AXESS
Location: Hertfordshire
Reference: PW 6627
Closing Date: 23 Dec 16
Type: Permanent
Salary (£): Competitive
Benefits: Corporate

Job Summary:

This is a newly created role within this global Pharma company which will take responsibility for overseeing clinical disclosure and transparency activities. This would suit a candidate with a background in pharma clinical research or regulatory affairs and working experience of clinical transparency rules looking to lead major projects and work with key stakeholders globally across the business.

Requirements:

BACKGROUND:

Leading global pharmaceutical company
Hertfordshire based

 

PRIMARY DUTIES:

·         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.

 

TO APPLY:

For a confidential discussion please telephone Anette Gillan at AXESS Limited on 020 8560 2300. To apply, please send your CV to jobs@axess.co.uk quoting reference PW 6627

 

Keyword:

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

 

ABOUT AXESS:

AXESS has been operating since 1990

We are a recruitment business dedicated to the pharmaceutical industry, specialising in Medical Affairs, Regulatory Affairs & Clinical Development

We match professional candidates to the best permanent, contract and interim roles in the market

Visit us at www.axess.co.uk

 

Apply for this job:  PW 6627 Manager, Data Quality and Standards (Clinical Trials Disclosure)

Contact Information:

Address:  Head Office
Isabella House,
12 Union Court,
Richmond upon Thames,
Surrey
TW9 1AA
England
Tel:  +44 (0)20 8560 2300
Fax:  +44 (0)20 8560 2033
Website:  Visit Our Web Site

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