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Senior Clinical Research Associate - D

Abbott Park, ILRandstad LifeSciences

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Job Title:  Study Project Manager I 

Position Description

  • The Study Project Manager is responsible to connect science and operations to bring clinical studies to life through the execution of one or more Phase 1-4 clinical research studies. Contributes clinical operational strategies to ensure clinical research studies are executed with quality and efficiency, on-time, within budget, and meet company objectives. The study project manager achieves these objectives via scientific expertise, strategic thinking, a global mindset and innovative solutions to address risks and challenges.

Position Responsibilities

  • Responsible for executing clinical studies in compliance with quality standards (ICH/GCP, Global Regulations, and company policies and procedures).
  • Leader of the cross functional study team:
    • Leads Clinical Study Team Meetings
    • Project manager for clinical studies leveraging the clinical schedule; manages the critical path and milestones
  • Responsible for regular updates to the cross-functional team and stakeholders on study status; ensures our CTMS is up to date
  • Responsible for regular updates to the cross-functional team and stakeholders on study status; ensures our CTMS is up to date
  • Responsible for the development of the clinical study design and associated systems and documents (for example: Informed consent forms, eCRFs, IRT, CSR)
  • Responsible for study budget creation and oversight of spend against approved budget
  • Responsible for the vendor selection, scope development, management and oversight of external vendors in compliance with company's processes and procedures and the applicable regulations
  • Responsible for generating the study related training for the study team, study sites, and vendors for assigned studies
  • Proactively identify and address and/or escalate study related issues and opportunities for efficiency
  • Decision maker on operational aspects of study execution.
  • Participates in innovation and process improvement initiatives.
  • Provides direct supervision of study management associate(s) including career development of clinical operations staff and creating an inclusive and innovative environment where staff and studies/programs will succeed

Position Requirements

  • Bachelor's Degree or equivalent is required, typically in nursing or scientific field; Associate's Degree, R.N., or equivalent with relevant experience is acceptable.
  • Must have at least 6 years of Pharma-related/clinical research related experience.
  • Demonstrates a high level of core and technical competencies through management of various components of clinical trials.
  • Possesses good communication skills and demonstrated leadership abilities.
  • Demonstration of successful coaching/mentoring in a matrix environment.
  • Competent in application of standard business procedures (Standard Operating Procedures, International Conference on Harmonization (ICH), Global Regulations, Ethics and Compliance).
  • Preferred exposure in study initiation through Study completion in multiple phases of studies (Phase 1-3,4)


  • Medical, Dental, and Vision Insurance
  • 401K Plan with Company Match
  • Life and AD&D Insurance

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