Amgen Clinical Data Mgmt Mgr in South San Francisco, California
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
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.
Global Study Operations (GSO) - Data Management plans and executes the capture, cleaning and storage of all Amgen clinical study and trial management data.
Reporting to the Senior Manager-GSO Data Management, the Clinical Data Mgmt Mgr will be the Project Lead role within GSO DM. Amgen GSO-DM is strategically resourced with significant external vendor support through a functional service provider (FSP) model.
The GSO-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.
The Clinical Data Management Manager 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).
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 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
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 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.)
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.
Amgen will consider for employment qualified applicants with criminal histories in a manner consistent with the San Francisco Fair Chance Ordinance.