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AX-7154 Lead Clinical Data Manager

AXESS Published: 22nd October 2018
Location
West London / Cambridge, United Kingdom
Job Type

Description

Ref: AX-7154

JOB SUMMARY

Opportunity to lead clinical data management projects globally for a leading biotech company. Responsible for data management projects throughout the study life cycle whilst collaborating with internal teams and vendors.

 

BACKGROUND

  • A global role within a busy and dynamic working environment.
  • Fantastic broad ranging pipeline across multiple therapy areas
  • Excellent career development and training opportunities
  • Opportunity to be involved in wider process development and improvement activities

 

PRIMARY DUTIES

Lead or participate in the development, review and implementation of processes, policies, SOPs and associated documents affecting DM

Contribute to development of DM outsourcing strategies and long-term relationships with CRO partners / external vendors

Oversight of FSP vendors with respect to quality, Issue & CAPA tracker & KPI metrics

Provide DM product level input to developing and managing resource plans and budgets for DM

Manage vendor deliverables and relationship at the project level

Lead electronic submission activities

 

QUALIFICATIONS / EXPERIENCE REQUIRED:

  • Life Science or equivalent degree
  • Pharmaceutical, CRO or biotech clinical data management experience in a global team
  • Oversight of clinical research vendors including CRO’s and central labs
  • Knowledge of Good Clinical Practice, Drug development and clinical trials processes, clinical trial databases and applications, Quality Management, Regulatory filings and inspections, Risks analysis, Process improvement methodologies is essential

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.

 

BENEFITS:

Comprehensive

 

TO APPLY:

For a confidential discussion please telephone Sukhveer Gill at AXESS Limited on 020 8560 2300.

To apply, please click APPLY ONLINE.

 

KEYWORDS:

Lead Clinical Data Manager, Senior Clinical Data Manager, Clinical Data Manager, Senior Clinical Data Manager, Data Manager, Study Data Manager, data management, study data management, Clinical Data Management, Senior Clinical Data Manager, Data Manager, Clinical Data Manager, contractor Clinical Data Manager, interim clinical data manager, clinical data management, London, capa, FSP, CRO

 

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

 

 

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