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For your reference, we have included the original job posting below.
Senior Associate Clinical Data Management - Oncology
Job Number:
41708849
Company Name:
Amgen
Job Location:
South San Francisco, CA US
Job Categories:
Clerical & Administrative Research
Senior Associate Clinical Data Management - Oncology
The Sr Associate Clinical Data Management position is a Lead Clinical Data Manager role on the global oncology study team, with responsibility for coordinating all CDM activities and oversight of the CRO. This role can be based at Amgen's Thousand Oaks, CA headquarters or Amgen's South San Francisco site. Howevver, the preference is for the candidate to be located at Amgen's Thousand Oaks headquarters.
Responsibilities include:
Ensuring all Clinical Data Management (CDM) procedures and processes meet business requirements and are adhered to
Ensuring that study timelines are met
Coordinating CDM activity for assigned study teams
Management and oversight of contractors and external vendors for specific studies
Facilitating preparation of CDM documentation
Participation in process improvement initiatives relating to CDM
Communication within their assigned study teams globally
Review of all documents for assigned study or studies
Develop and review Data Management Plans and Study Definition Matrix documents
Lead CDM representation on assigned study teams e.g. Clinical Study Team (CST) including attendance and/or presenting at investigator/Clinical Research Associate (CRA) meetings
Study level coordination of staff
Assign Protocol Deviations
Participate in CDM process improvement forums
Study level resource management in conjunction with the CDM representative to the Global Development Team (GDT)
Assist in selection of insourcing / outsourcing partners for assigned studies including input to Request for Proposal (RFP)
Participate in development and review of policies, SOPs and associated documents for CDM
Assist with development of Case Report Forms (CRF)
Attend relevant focus group and committee meetings e.g. Clinical Data Interchange Standards Consortium (CDISC), Oracle Clinical User Group (OCUG), Association for Clinical Data Management (ACDM/SCDM) etc.
Participate in cross-functional international working groups
Maintain global collaboration
Promote and be an advocate of CDM internally and externally
Facilitation of inter / intra departmental communication
Basic Qualifications Master's degree OR Bachelor's degree & 2 years of directly related experience OR Associate's degree & 6 years of directly related experience OR High school diploma / GED & 8 years of directly related experience
Preferred Qualifications Bachelors degree in life science(s), computer science, business administration or related discipline
4 or more years work experience in clinical data management in the Pharmaceutical or Biotech arena
2 or more years experience in managing study level projects
Experience in Oncology
Knowledge:
Good Clinical Practice Drug Development and Clinical Trials Processes Data Management Processes Clinical Trial Databases and Applications Ability to understand technical, scientific and medical information Good organizational and planning skills Project Management Effective working in a team/matrix environment Quality Management Vendor Oversight
