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Job Details

PW 6640 Senior Clinical Data Manager

Company: AXESS
Location: Hertfordshire
Reference: PW 6640
Closing Date: 23 Dec 16
Type: Permanent
Salary (£): Competitive
Benefits: Corporate

Job Summary:

This role will sit within this global pharma company’s data services group and provide data management support to studies in a key oncology program. This can involve either leading data management activities on a specific project or providing hands on support to other studies in the program. This company offers a collaborative working environment with excellent progression opportunities.

Requirements:

BACKGROUND:

Leading global pharmaceutical company
Hertfordshire based

 

PRIMARY DUTIES:

Study Start Up:

Leads DM Study Start Up activities (CRF Design/ Data Validation Specifications/ Query Handling Guidelines, etc.)

Provides Site/ Investigator training

Leads User Acceptance Testing

Provides review of Protocols for consistency check

 

Study Conduct:

Leads SAE reconciliation

Generates and reviews metrics reports for data monitoring

Manages study-level medical coding and cross-functional study-level query management and data review listing activities

 

Study Close-Out:

Compiles Data Management Plan documentation

Manages database lock activities: Final SAE reconciliation/ final data review, study decommission etc.

 

Data Standards:

Adheres to data standards and proper data validation processes

 

Outsourced Activities:

Liaises with vendors to achieve targeted deliverable dates and ensure data quality is achieved in accordance to set standards

Manages the delivery and reconciliation of external data

 

Resource Management:

Recognizes when current resources (tools, systems, vendors, etc.) need improvements and communicates to responsible supervisors

 

Financial Management:

Tracks the expenses of work teams to identify cost issues

Follows function’s financial standards, guidelines and compliance requirements

 

Matrix and Team Management:

Provides feedback to peers in a constructive manner

Supports employees by participating in project initiation, work transitions, and other development activities

May conduct training where appropriate

 

Compliance:

Complies with all applicable laws / regulations of each country in which we do business

Demonstrates high ethical behavior at all times, whether dealing with colleagues, vendors, patients, or physicians

Reports legal, compliance and ethical violations in a timely manner

 

QUALIFICATIONS / EXPERIENCE REQUIRED:

BS/MS in relevant field

Experience in data management methods and processes in pharma industry setting required

Oncology and InForm experience preferred

 

TO APPLY:

For a confidential discussion please telephone Andrea Litovszky at AXESS Limited on 020 8560 2300. To apply, please send your CV to jobs@axess.co.uk quoting reference PW 6640

 

Keyword:

Study Data Manager, data management, study data management, Clinical Data Management, Senior Clinical Data Manager, Data Manager

 

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 6640 Senior Clinical Data Manager

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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