General Information

Location: Remote

Organization: ACI Clinical

Job Type: Part Time – Temporary

Description and Requirements

SUMMARY OF POSITION:  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.

EDUCATION REQUIREMENTS:

·       BS/BA or equivalent experience required.

VACCINATION REQUIREMENT:

To be considered for U.S.-based positions unless currently employed by WCG, where permitted by applicable law (including any applicable reasonable accommodation, medical or religious exemption), candidates must have received or be willing to receive the COVID-19 vaccine by start date.

QUALIFICATIONS/EXPERIENCE:

  • 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.

ESSENTIAL DUTIES/RESPONSIBILITIES: To perform this job successfully, an individual must be able to perform each essential duty and responsibility satisfactorily.  The requirements listed below are representative of the knowledge, skills, and/or ability required.

  • 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.
  • Other duties as assigned by supervisor. These may, on occasion, be unrelated to the position described here.
  • Attendance and punctuality are essential functions of the position.

SUPERVISORY RESPONSIBILITIES: None.

TRAVEL REQUIREMENTS: None.