Senior Associate Study Manager

Location: Thousand Oaks, CA
Date Posted: 06-22-2018
Day to Day Responsibilities:
  • Onboard to Amgen Early Development trainings.
  • Familiarize with Amgen system to immediately contribute to support activities.
Summary
  • To assist in the execution of clinical trials and to continue development of skills/knowledge in the management of clinical research.
  • The incumbent will report to Clinical Research Study Manager.
Responsibilities:
  • Work with the clinical trial management staff (associates and managers) to support the execution and monitor clinical studies and achieve of clinical trial deliverable.
  • Monitoring of study deliverables
  • Performing protocol-related site management activities
  • Participating in study planning and set- up activities including vendor management, project management, and coordination of study and implementation plans
  • Supporting vendor relationships
  • Serving as one of the first points of contact within Early Development for study-related issues
Key Activities:
  • Contribute to the design, content, and preparation of study concept documents, clinical protocols, amendments, consent forms, study guides, monitoring plans, (e)CRFs, and subject information sheets
  • Assist in the identification and evaluation of clinical trial investigators and Phase 1 and
  • Phase 2a clinical research units
  • Contribute to, or coordinate preparation and conduct of site initiations, monitors workshops (as applicable) and investigator meetings (as applicable)
  • Work with the Clinical Research Study Managers and Clinical Scientist(s) to develop recruitment strategies
  • Coordinate study-level investigational product arrangements and accountability and reconciliation
  • Participate in, and support study teams
  • May author monitoring plans, monitor study sites, complete monitoring reports, and have more direct responsibility for study start-up activities and site management
  • Coordinate activities associated with site start-up and management including review site-modified informed consent templates and tracking of the budget and contract process
  • Provide input for screening and enrolment progress
  • Provide extensive clinical site/clinical field operations support by answering protocol- specific questions
  • Work with the Clinical Research Study Manager and Clinical Scientist(s) to resolve patient eligibility questions and protocol deviation
  • May assist with the preparation and conduct of DLRM
  • Work with BSM and assay groups (i.e. PKDM, Clinical Immunology, Molecular
  • Science) to coordinate shipment and analysis of clinical biological samples
  • Identify barriers to screening and enrolment and provide solutions
  • Support and monitor CRO, FSP and third party vendor activities, including
  • relationships and training, and the development of vendor specifications and scopes of work
  • Using relevant reports, identify progress of (e)CRF data collection and query resolution
  • Monitor progress of studies, identify study-related trends/issues and work with the clinical research manager to implement corrective actions when necessary
  • Provide input to the clinical study team for the creation of clinical study timelines and budgets
  • Assist in the processing and distribution of essential documents for archiving in the
  • Trials Master File
  • Provide input to and maintain administrative systems (i.e., eClinical)
  • Prepare and communicate regular updates to study team
  • Support preparation and quality control of protocols, clinical study reports, regulatory submissions, and publications
  • Continue to increase knowledge of clinical research, clinical operations, and relevant therapeutic area(s)
  • Contribute to the continuous improvement of Early Development
  • Role Qualifications, Experience, Knowledge & Competencies
Basic Qualifications:
  • BA/BS/BSc or RN
  • 3 years work experience in life sciences or medically related field
  • At least one year of biopharmaceutical clinical research experience (clinical research experience obtained working on industry-sponsored or industry-partnered clinical trials at academic institutions, or working on clinical trials at a biotech, pharmaceutical or CRO company)
Preferred Qualifications
  • BA/BS/BSc in the sciences or RN
  • 5 years work experience in life sciences or medically related field, including 2 years of biopharmaceutical clinical research experience obtained as follows:
  • Clinical research experience obtained working on industry-sponsored or industry- partnered clinical trials at academic institutions, or working on clinical trials at a biotech, pharmaceutical or CRO compan
Knowledge
  • Ability to understand technical, scientific and medical information
  • Understanding of drug development process
  • Familiar with advanced concepts of clinical research
  • Advanced computer skills
  • Experience in interactions with outside vendors, e.g., CROs and contract labs
  • Experience with administration of site budgets and grants with supervision
  • Experience with development of prospective site-selection criteria
  • Detailed knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines, and applicable international regulatory requirements
  • Ability to write and present clearly using scientific and clinical issues terminology
  • Experience dealing with time demands, incomplete information or unexpected events
  • Good organizational and planning skills
  • Experience working effectively in a team/matrix environment
  • Key Competencies:
  • Attention to detail
  • Team work
  • Written and oral communication
  • Delivery focus
  • Flexibility
  • Initiative
  • Relationship building
  • Policy, process and procedural conformance
  • Problem solving
  • Time management
"This posting is for Contingent Worker, not an FTE"
 
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