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. To be considered for a current opening at ACI, you may submit your CV or resume here.

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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:

Serves as Project Manager on multiple expert committee and/or clinical trial projects, acting as the first line of communication between ACI and the Sponsor, demonstrating effectiveness in both servicing clients and assuring on-time delivery of high quality deliverables.

Specific responsibilities include:

  • Provide proactive leadership as the primary project leader for any assigned project.
  • Serve as primary liaison to Sponsor regarding assigned projects and/or programs.
  • Assure that project tasks and deliverables are properly executed and tracked according to defined budgets and timelines.
  • Manage project-specific budgets and timelines, including identification of changes in scope and preparation of change order budgets.
  • Support proposal development by providing 1) protocol-specific sections to proposal text and 2) specification as needed for budget development.
  • Provide regular (at least monthly) status reports to upper management.
  • Coordinate project team meetings and record and disseminate minutes of meetings.
  • Compile and retain study file for Sponsor.
  • Lead and/or participate in departmental initiatives.

REQUIREMENTS:

  • At least three (3) years experience in Project Management or related industry experience in pharmaceutical or medical device companies.
  • Knowledge of Drug and/or Device Study Development and/or clinical adjudication processes.
  • Strong organizational, communication, and time management skills required.
  • Knowledge of FDA, ICH and GCP guidelines as they apply to clinical studies and clinical data management.
  • Experience in developing and managing a budget.
  • BS/BA required or equivalent experience.
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.