Clinical Data Management Manager x2

Proclinical is currently recruiting for a Clinical Data Management Manager job at a leading multinational biopharmaceutical company with leading therapies in autoimmune diseases and oncology. They are seeking an individual to bring solid Data Management experience to their team at their offices in Uxbridge. This is an exciting opportunity to work for one of the world's biggest biotechnology firms that employs over 17,000 staff globally.

This Clinical Data Management Manager role will be working within a global team, Clinical Data Management Manager is responsible for ensuring clinical projects are executed according to set timelines with quality and consistency. The successful candidate may be responsible for one or multiple products depending on the complexity. The Clinical Data Management Manager will ensure that DM procedures and processes are adhered to by vendor staff through oversight of quality, cycle times, metrics and use the Issue CAPA process

Job Responsibilities:

• Training and mentoring of DM TA staff on processes, projects and programmes
• Lead or participate in the development, review and implementation of processes, policies, SOPs and associated documents affecting DM
• Participate in and/or lead DM and cross functional working groups
• Contribute to the continuous improvement of DM and the wider Development organization through information sharing, training and education
• 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
• Promote and be an advocate of DM internally and externally
• Represent DM at project team meetings i.e., GCST
• Project level coordination of and day to day oversight of DM tasks including:
• Review of all DM documents within a project area to ensure a consistent approach
• Overview of project timelines and metrics to ensure databases are delivered to set timelines
• Approve database locks and unlocks
• Actively monitor progress of clinical projects within assigned product area to ensure delivery to set timelines and quality standards
• Provide DM product level input to developing and managing resource plans and budgets for DM
• Ensure that quality control checks are occurring such that quality databases are delivered
• Review and approve study specific training
• Manage vendor deliverables and relationship at the project level
• Communication and escalation of project level issues including processes, timelines, resourcing, performance, etc
• Review of all study level non-DM documents for awareness and project level consistency
• Lead electronic submission activities
• Assist with response to questions and findings from Clinical Quality Assurance (Quality Assurance) and other audits at the study / vendor level

Skills and Requirements:

• Bachelors degree or equivalent in life science, computer science, business administration or related discipline
• Broad and proven experience in life sciences or a medically related field including experience in biopharmaceutical clinical research experience
• Extensive Data Management experience in a global organisation
• Previous experience at or oversight of outside clinical research vendors (CRO's, central Labs, vendors, etc.)
• 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

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Tom Magenis on + 44 203 854 1050 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.