Clinical Study resource III

  • location: Northbrook, IL
  • type: Contract
  • salary: $80 - $86 per hour
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job description

Clinical Study resource III

job summary:
As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. We are currently partnering with a company known for their leading clinical trials as well as Research & Development. With the goal to constantly develop innovative products, you will feel secure in the fact that you are making a difference. Apply for your dream job now!

 
location: Northbrook, Illinois
job type: Contract
salary: $80 - 86 per hour
work hours: 9 to 5
education: Bachelors
 
responsibilities:
The purpose of the position is to plan, initiate and execute clinical pharmacology studies with operational excellence. This position requires independent vendor management within studies and the training of and effective interactions with/coordination of study teams, vendors, and full service outsourcing providers.

  • Operationalize scientific concept including refining study design and providing feasibility assessment for complex study designs.
  • Lead cross-functional study teams in the operational planning, administration, and management of clinical pharmacology studies of any complexity, and/or collaborate with outsourcing provider in the execution of individual or packages of studies in compliance with SOPs, WPDs, BOGs, GCP/ICH, and other applicable regulatory requirements.
  • Lead development of CPED deliverables for study planning, administration, management, and reporting.
  • Collaborate with sites, vendors, and/or outsourcing partners to ensure operational excellence.
 
qualifications:
  • Bachelor's/Master's degree (or equivalent) with scientific or clinical background, monitor experience preferred
  • Requires at least 3-4 years of operational experience in conducting clinical pharmacology studies.
  • Working knowledge of GCP, FDA and/or EU Clinical Trials Directive guidance documents Experience with complex clinical pharmacology designs and drug development
  • Proven project management skills and study leadership ability
  • Excellent interpersonal, written, and verbal communication skills and computer ability
  • Experience with complex clinical pharmacology designs and drug development
  • Proven project management skills and study leadership ability
  • Excellent interpersonal, written, and verbal communication skills and computer ability
  • Fluent in English
  • Ability to analyze and explain complex study designs and when possible, recommend or implement improvements for operational efficiency and excellence; Innovatively obtain or apply resources to meet project goals.
  • In depth knowledge/understanding of GCP, FDA and/or EU Clinical Trials Directive guidance documents, and guidance documents for clinical pharmacology studies and conceptual understanding of basic PK and/or PD for increased depth and breadth of input to clinical pharmacology study outline development, protocol design and feasibility assessment, and data reporting discussions, and for briefing document/IND/IMPD/NDA/CTD document review.
  • Ability to understand and apply appropriate steps for study budgeting, contracting, invoice & payment tracking, and quarterly forecasting. Ability to apply prior study costing experience to future study budget planning for assigned studies or packages of studies.
  • Problem solving, critical thinking skills (i.e., Can Identify root cause and propose/implement reasonable corrective actions in the context of region-appropriate GCP regulations and guidances, SOPs, protocol, and industry best practices; Able to apply lessons learned from prior experience to novel challenges).
  • Decision-making skills (i.e., Ability to provide on- the-spot decisions for complex problems, but consults with supervisor for feedback or escalation, if needed).
  • Proactive thinking skills (i.e., Can anticipate problems and take appropriate actions to avoid them).
  • Competent presentation skills (i.e., Verbal and visual presentations are logical, organized, accurate, and understandable).
  • Excellent writing skills (i.e., Concise, accurate, unambiguous style without typos and grammatical errors).
  • Excellent oral communication skills (i.e., Can describe experiences clearly and concisely and then if necessary provide details).
  • Highly motivated, self-directed (i.e., Ability to work independently); Follow through on commitments.
  • Organized and goal-oriented (i.e., Can independently break down and prioritize large tasks into achievable goals for completion. Can anticipate future project demands and plan accordingly.
  • Aware of status of tasks/milestones of assigned projects and delegated or outsourced activities;
  • Does not lose track of critical details that could risk GCP/SOP/protocol adherence or project goals/costs/ timelines).
 
skills: IND, NDA, SOP, Vendor Management, GCP (Good Clinical Practice), Clinical Study Design, CTD Structure, ICH Regulations
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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