The Global Study Operations-Data Management (DM), Manager (Project Lead) role will partner with cross functional study team as well as our functional service provider (FSP) to ensure product delivery of the Amgen Therapeutic Area (TA) portfolio.
This individual achieves results through rigorous goal setting, accountability measures, effective teamwork, performance management, collaboration with other groups and a commitment to serving customers both inside and outside of Global Study Operations (GSO).
This individual will ensure a focus on timely quality delivery as well as consistency across the Data Manager components. All results will be achieved in a manner that embodies Amgen culture and values; collaboration and teamwork, ethics, and staff development.
Responsibilities include, but are not limited to, the following:
Training and mentoring of DM TA staff on processes, projects and programs
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
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:
Co-ordination of lead DM’s within the project
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
Ensure that quality control checks are occurring such that quality databases are delivered
Develop and co-ordinate project level training for data management staff
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
Doctorate degree OR
Master’s degree and 3 years of clinical experience
Bachelor’s degree and 5 years of clinical experience
Associate’s degree and 10 years of clinical experience
High school diploma / GED and 12 years of clinical experience
Bachelor’s degree or equivalent in life science, computer science, business administration or related discipline
6+ years work experience in data management in the Pharmaceutical or Biotech arena
3+ years project management and planning experience
Experience in oversight of outside vendors (CRO’s, central labs, imaging vendors, etc.)
The GSO DM Manager – Project Lead will be a highly motivated, decisive and results-oriented individual with the flexibility and creativity to excel in a multi-project, high-pressure environment. This role will have extensive clinical trial experience and leadership expertise. He or she will be a strategic & driven leader who will identify and implement opportunities, be passionate about improving efficiencies and gain consistency across DM delivery processes. With strong negotiation skills; he or she will be able to address conflict head-on and facilitate
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.