Ref #: 26991

Employment type: Permanent - Full-Time

Location: Mexico City

Posted: 17-Feb-2021

Description

Responsibilities:
• Ensuring clinical projects are executed according to set timelines with quality and consistency
• Leading DM activities for a given project or multiple projects
• Ensuring that DM procedures and processes are adhered to by FSP staff through oversight of quality, cycle times, metrics and use of the Issue CAPA process
• Co-ordination of associate SDM (aSDM) within assigned projects

Key Activities:
• Responsible for the project deliverables such as:
o Planification of all data management activities, considering the overall study timelines
o Protocol review and defining data collection strategy
o eCRF design and review
o Defining data cleaning and validation strategy integrating risk-based approach
o Data Management Plan and Centralized Monitoring Plan
o Review of all other DM documents within a project area to ensure a consistent approach
o Coordinating vendor external data activities: load, integration activities and reconciliation activities, including External Lab data, eCOA, IRT integration etc.
o Database locks and unlocks
o Actively monitor progress of clinical projects within assigned product area to ensure delivery to set timelines and quality standards
• Represent DM at study team meetings
• Communication and escalation of project level issues including processes, timelines, resourcing, performance, etc..
• Co-ordination of aSDM within the project
• Develop QC strategy and ensure that quality control checks are occurring such that quality databases are delivered
• Oversight of FSP vendors with respect to quality, Issue & CAPA tracker & KPI metrics
• Manage vendor deliverables and relationship at the project level
• 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 including participating in project level audit
• Lead or participate in the development, review and implementation of processes, policies, SOPs and associated documents affecting DM

Experiences, Skills and Knowledge:
Experience
• 6+ years work experience in data management in the Pharmaceutical or Biotech area
• 3+ years project management and planning experience
• Experience in oversight of outside vendors (CROs, central labs, imaging vendors, etc.)

Knowledge
• Regulatory guidelines, GCP and industry standards
• Drug development and clinical trials processes
• Data management processes
• Clinical trial databases and applications
• Systems development lifecycle
• Project planning and management
• Medical / life sciences in several therapeutic areas
• Quality management
• Vendor oversight
• Regulatory filings and inspections
• CDASH / SDTM Basics

Key competencies
• Teamwork
• Attention to detail
• Written and oral communication
• Problem solving
• Relationship building
• Project management
• Leadership skills
• Strategic thinking

Education
• Bachelor’s degree or above in life science, computer science or related discipline

Must have total fluency in English