Interested in joining a team that is helping biopharmaceutical companies mitigate risk and enhance patient safety in clinical trials? ACI Clinical provides an exciting and intellectual work environment complete with rewarding growth and development opportunities for talented, motivated people. We’re always looking for individuals with drive and a spirit geared for innovation.

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ACI Clinical is a fast growing company which provides high-value services for clinical trials. We are seeking highly competent, self-motivated individuals who can interact successfully with senior executives from pharmaceutical and biotechnology companies as well as our panel of over 500 expert physicians and scientists throughout the world.

The successful candidate should enjoy taking responsibility for their actions and having the opportunity for personal and professional growth. In addition to a work environment that supports independent decision-making, we offer flexible schedules with highly competitive salary and benefits.

RESPONSIBILITIES:

  • Lead Programmer in DMC Reporting environment
  • Lead a team of programmers in supporting DMC programming needs
  • Assist Biometrics Department with developing tools and techniques for improving process efficiencies.
  • Perform quality assurance procedures, as required, on work performed by others.
  • Review statistical analysis plans and protocols.
  • Contribute to the development and documentation of analysis/clinical data set specifications, safety and efficacy analysis programming, as well as any ad-hoc programming requests.
  • Develop and maintain Programming standard and custom data listings, summary tables, and graphs as specified in statistical analysis plan.
  • Implement and follow the latest versions of CDISC, FDA guidelines, Good Clinical Practice, and other industry standards.
  • Provide input into case report form design, database structure design, and edit check development.

REQUIREMENTS:

  • At least Eight (8) years industry experience.
  • Demonstrated proficiency in using SAS to produce derived analysis datasets and TFLs.
  • Demonstrated skill in generating outputs to support downstream analysis requirements, e.g., ADaM specification and datasets creation, CSR Tables, Figures and listings, Supported analysis for DMCs, Generation of Data Definition Tables and CDISC submissions
  • Demonstrated expertise in SAS programming, Trial Designs, Statistical and Graphical Procedure, Controlled Terminology
  • Demonstrated experience in developing and using SAS macro for building efficient data tabulations and analysis
  • Demonstrated ability to coordinate project deliverables.
  • Strong written and verbal communication skills.
  • BS or BA required; degrees in computer science, math or sciences preferred.
ACI Clinical is a fast growing company which provides high-value services for clinical trials. We are seeking highly competent, self-motivated individuals who can interact successfully with senior executives from pharmaceutical and biotechnology companies as well as our panel of over 500 expert physicians and scientists throughout the world. In addition to a work environment that supports independent decision making, we offer highly competitive salary and benefits.

The Clinical Specialist Primary responsibility for clinical review to assure data completeness and accuracy, consistency, logic, medical accuracy, patient safety and protocol compliance. Additionally provide clinical support for Panel Meetings, including documentation of decisions and coding and preparation of clinical summary

 RESPONSIBILITIES:

  • Perform tasks for assigned projects according to defined budget and timeline for designated workflows
  • Primary responsibility for clinical review to assure data completeness and accuracy, consistency, logic, medical accuracy, patient safety and protocol compliance
  • Clinical review of case content that includes source documents such as procedure reports and hospitalization summaries
  • Provide clinical support for Panel Meetings, including documentation of decisions and coding and preparation of clinical summary
  • Perform serious adverse event reconciliation
  • Perform coding of adverse events, concomitant medications and medical history
  • Supporting Charter development with regard to clinical aspects
  • Clinical leadership in defining Event Identification Processes

REQUIREMENTS:

  • BS/BA required or equivalent experience; nursing degree preferred.
  • At least three (3) years industry experience, CRA or nursing experience preferred.
  • Superior organizational skills.
  • Excellent attention to detail.
  • Outstanding communication skills.
  • Ability to handle fast-paced environment.