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Senior Associate Study Manager

South San Francisco, CA
Day to Day Responsibilities:     
  • Onboard to Amgen Early Development trainings.
  • Familiarize with Amgen system to immediately contribute to support activities.
  • Ideal Candidate-High functioning clinical trial associate (CTA)/Junior level clinical trial manager who is able to perform daily clinical trials activities, as well take on stretch responsibilities such as writing and review critical trial documents, as well as oversee vendor startup and management
  • 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.
  • 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 infomed 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
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 company
  • 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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