Clinical Data Mgmt – Manager

  • Company: Amgen
  • Posted: January 18, 2017
  • Reference ID: R-32868
The GSO DM Manager- Project Lead role will partner with cross functional study team as well as 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.
Responsibilities include, but are not limited to, the following:
Ÿ Training and mentoring of DM TA staff on processes, projects and programs
Ÿ Lead or participate in the development, review and implementation of processes, policies, SOPs and associated documents affecting DM
Ÿ Participate in and/or lead DM and cross functional working groups
Ÿ Contribute to the continuous improvement of DM and the wider Development organization through information sharing, training and education
Ÿ Contribute to development of DM outsourcing strategies and long-term relationships with CRO partners / external vendors
Ÿ Promote and be an advocate of DM internally and externally
Ÿ Represent DM at project team meetings i.e., GCST
Ÿ Project level coordination of and day to day oversight of DM tasks including:
Ÿ Co-ordination of lead DM's within the project
Ÿ Review of all DM documents within a project area to ensure a consistent approach
Ÿ Overview of project timelines and metrics to ensure databases are delivered to set timelines
Ÿ Approve database locks and unlocks
Ÿ Ensure that quality control checks are occurring such that quality databases are delivered
Ÿ Develop and co-ordinate project level training for data management staff
Ÿ Review and approve study specific training
Ÿ Manage vendor deliverables and relationship at the project level
Ÿ Communication and escalation of project level issues including processes, timelines, resourcing, performance, etc.
Ÿ Review of all study level non DM documents for awareness and project level consistency
Ÿ Lead electronic submission activities
Ÿ Assist with response to questions and findings from Clinical Quality Assurance (Quality Assurance) and other audits at the study / vendor level
Basic Qualifications
Ÿ Doctorate degree OR
Ÿ Master's degree and 3 years of clinical experience
Ÿ Bachelor's degree and 5 years of clinical experience
Ÿ Associate's degree and 10 years of clinical experience
Ÿ High school diploma / GED and 12 years of clinical experience
Preferred Qualifications
Ÿ Bachelor's degree or equivalent in life science, computer science, business administration or related discipline
Ÿ 6+ years work experience in data management in the Pharmaceutical or Biotech arena
Ÿ 3+ years project management and planning experience
Ÿ 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.

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