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Associate Clinical Study Manager

New Jersey All, NJ

Posted: 03/27/2019 Job Type: Clinical Job Number: JN -032019-24434
  • Responsible for hands-on management and tracking of all aspects of the clinical research program(s) and/or non-interventional study program(s)
  • Adjusts priorities and demonstrates adaptability, identifies and implements new or different ways to achieve goals
  • Identifies, analyzes, and communicates problems, issues, and opportunities
  • Develops and implements effective solutions to achieve desired outcomes
  • Lead Registry process improvement initiatives
  • Completes assigned tasks within functional team
  • Assist with any special projects as assigned
  • Expected to provide valuable input on plans & decisions
  • Evaluates and manages time and resources effectively
  • Knowledge of the drug development process in the planning and management of clinical studies
  • Develops and delivers information in a clear and concise manner within company and clinical research guidelines
  • Listens actively and shares relevant information with others
  • Develops effective working relationships with business partners to achieve business goals
  • Demonstrates an understanding of clinical research processes and industry competition
  • Understands the disease state and treatment options
  • Develops project plans and manages multiple projects to achieve goals within established timelines
  • Ability to create and deliver a presentation
  • Collaborates to identify strengths and developmental areas; creates, owns, and implements professional development plan
  • Responsible for implementing plans & decisions in collaboration with Study Manager
  • Support the Study Manager in creating, updating, reviewing and tracking Study Plans
  • Maintain, track and report on study metrics, in conjunction with CRO
  • Support the Study Manager in creation of the study feasibility questionnaire and consolidation of responses, and follow-thru of the site acceptance process
  • Process CDA and contract requests
  • Create and maintain Study Document Shared Locations for assigned study(ies) on SharePoint or on appointed shared drive
  • Communicate with the sites, or designated CRO staff, through direct contact and other methods regarding study specific issues, as requested
  • Track study progress including patient enrollment and site status
  • Process and track payments to vendors, Scientific Steering Committee and study sites as appropriate
  • Participate in CRO Oversight activities, such as generation and/or distribution of study specific documents and tools
  • Generate, finalize and distribute study team agendas and meeting minutes
  • Assist with the preparation and review of Informed Consent Documents (ICDs)
  • Perform Trial Master File (TMF) Quality Review according to SOPs and WPs
  • Support planning and logistics for meetings including investigator meetings, study team meetings, and meetings with CROs and other vendors
  • Participate in other activities including but not limited to essential document review and tracking, TMF set-up, and coordination of study specific binders
  • Participate in SOP and WP development, as requested
  • Participate or provide leadership in departmental initiatives
Required Competencies-Knowledge, Skills, and Abilities:
  • Completed BA/BS in directly-relevant discipline
  • 3-5 years of experience in the pharmaceutical, CRO, or healthcare environment(s) required
  • Oncology experience is strongly preferred
  • Experience working with non-interventional study program(s) is strongly preferred
  • Strong verbal and written communication skills
  • Strong organizational skills
  • Ability to work collaboratively, effectively, and productively in diverse organization structures
  • Team player and ability to build relationships
  • Ability to demonstrate leadership capabilities
  • Solid computer skills and practical knowledge of MS Word, Excel, PowerPoint and project management software
  • Knowledge of clinical research databases, especially EDC
  • Ability to create and deliver presentations to management or team members
  • Must be flexible and manage change easily
  • Ability to work positively within a continually changing environment
  • Ability to problem-solve
  • Ability to effectively prioritize and execute tasks in a high-pressure environment
  • Familiarity with ICH / GCP and regulatory guidelines/directives
  • Knowledge of medical/scientific terminology

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