Associate Manager- Disease Registry

  • Type Contract
  • Salary competitive
  • Location Summit, New Jersey
  • Sectors Pharma & Biotech

Title: Associate Manager

Duration: 12 Months

Location: Summit, NJ

Compensation: Competitive

Hours expected: 40 hours per week

Benefits: Real Staffing offers medical, dental, vision, 401K, voluntary life insurance, short term/long term disability.

Description: The Associate Manager, will, under the direction of the Associate Director, Clinical Studies, provide support in the daily activities of managing and coordinating the operational efforts in the development and implementation of research-driven, clinical research programs and/or non-interventional study programs with close collaboration with the study team and clinical research sites. The individual will be responsible for hand-on management and tracking of all aspects of the clinical research programs and/or non-interventional study programs.

Day to Day Duties/Responsibilities/ Scope of Work

  • 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:

  • Ability to work collaboratively, effectively, and productively in diverse organization structures
  • Solid computer skills and practical knowledge of MS Word, Excel, PowerPoint and project management software
  • Knowledge of clinical research databases, especially EDC
  • Familiarity with ICH / GCP and regulatory guidelines/directives
  • Knowledge of medical/scientific terminology

Education & Experience:

  • Completed BA/BS in directly-relevant discipline or equivalent experience required
  • 3-5 years of experience in the pharmaceutical, CRO, or healthcare environment(s) required
  • Knowledge of drug development process, FDA, ICH, and GCP guidelines
  • Oncology experience is strongly preferred
  • Experience working with non-interventional study program(s) is strongly preferred

Sthree US is acting as an Employment Business in relation to this vacancy.