AX-7154 Lead Clinical Data Manager
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.
- 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
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.
For a confidential discussion please telephone Sukhveer Gill at AXESS Limited on 020 8560 2300.
To apply, please click APPLY ONLINE.
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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