This position can be located in Thousand Oaks or San Francisco, CA
The Global Study Operations (GSO) Data Management Manager- Project Lead role will partner with cross functional study team, as well as, Full Service Provider (FSP) to ensure product delivery of the Amgen Therapeutic Area 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 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.
Training and mentoring of Data Management (DM) Therapeutic Area (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., Global Clinical Study Team (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
Master's degree & 3 years of clinical experience
Bachelor's degree & 5 years of clinical experience
Associate's degree & 10 years of clinical experience
High school diploma / GED & 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.)
Highly motivated, decisive and results-oriented with the flexibility and creativity to excel in a multi-project, high-pressure environment.
Extensive clinical trial experience and leadership expertise.
Strategic & driven leader who will identify and implement opportunities, be passionate about improving efficiencies and gain consistency across DM delivery processes.
Strong negotiation skills, ability to address conflict head-on and facilitate rapid resolution.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.