Clinical Data Management Manager
The Role :
Working within a global tea, 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
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
Basic Qualifications and preferred experience :
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
Location : Cambridge, Uxbridge
Competitive salary & comprehensive benefits package including bonus scheme
The company :
Amgen is one of the world’s largest independent biotechnology companies, with global revenue of $23 billion and nearly 20,000 employees globally.
For more than 35 years, Amgen has pioneered biotechnology breakthroughs, to bring state-of-the-art medicines from laboratory to the patient.
Amgen has not only discovered and developed innovative human therapeutics, but has invested in cutting edge manufacturing capability and support services to deliver these exciting therapies to medical teams around the world.