Job Description

Employment Type: Full-time

Position Overview

This role supports Clinical Project Managers (CPMs) in the administration, execution, and close-out of clinical projects. The position involves document development, meeting participation, cross-functional liaison, and financial support activities. The role also focuses on monitoring project progress, ensuring adherence to timelines, and maintaining quality service standards.

Primary Responsibilities

• Project Administration:

  • Assists Clinical Project Managers with project administration by:
    • Developing project-related documents.
    • Reviewing and editing project presentations.
    • Participating in project meetings, conference calls, and training calls.
    • Reading and understanding project protocol documents.
    • Acting as a liaison with cross-functional team members to ensure timely completion of all study deliverables.
    • Reporting study needs and issues.
    • Supporting overall project start-up, execution, and close-out activities.
  • Supports project finance-related activities such as:
    • Assistance with documentation / database updates due to project scope changes.
    • Follow-up related to invoice reconciliations.
    • Preparation of project reports in support of project forecasting activities.

• Project Progress Monitoring & Communication:

  • Assists Clinical Project Managers in maintaining, reviewing, and communicating project progress by:
    • Monitoring internal data flow to ensure completion of tasks within agreed-upon timeframes.
    • Responding to inquiries in a professional, courteous, and timely manner.
    • Communicating with clients regarding project status.
    • Verifying protocol imaging requirements are met and queries appropriately identified.
    • Serving as acting Project Manager in the absence of the assigned Project Manager.
    • Creating, reviewing, and distributing (internally and/or externally) project report(s).

• Timeline Adherence & Client Support:

  • Ensures the development and adherence to project timelines by:
    • Following up on outstanding items including missing data, incomplete paperwork, queries, etc.
    • Assisting in tracking and resolving of client issues.
    • Serving as an additional point of contact to client, sites, sponsors, etc.
    • Supporting Logistics with the distribution, management, and tracking of site-facing materials.
    • Keeping clinical project manager(s) (CPM) and supervisor advised of current issues.

• Quality Service & Standards:

  • Maintains Quality Service and Departmental Standards by:
    • Reading, understanding, and adhering to organizational Standard Operating Procedures (SOPs).
    • Executing technical and clinical functions as required by the study protocol in accordance with Clario’s GCP’s, ICH and FDA Guidelines.
    • Reviewing and providing recommendations to management on operational procedures, and by participating in process improvement initiatives.

Secondary Responsibilities

• Team Contribution:

  • Contribute to Team Effort by:
    • Helping internal and external customers to achieve results.
    • Attending project-specific, system, and team-focused trainings.
    • Performing other duties as assigned.

• Technical Knowledge:

  • Maintains Technical Knowledge by:
    • Attending and participating in applicable company-sponsored training.

Qualifications

• Education:

  • Associate's Degree required.
  • Bachelor's Degree preferred.

• Experience:

  • 1+ years of experience working in pharmaceutical drug development, clinical trials, and/or clinical research preferred.
  • Strong experience with and knowledge of the Microsoft Office suite of software productivity tools.
  • Healthcare, medical experience, and/or clinical research experience preferred.

• Additional Skills:

  • Strong organizational, interpersonal, time management, and prioritization skills.
  • Excellent interpersonal, verbal, and written communication skills, including the ability to communicate effectively in English.
  • Detail-oriented, meticulous, and responsive to inquiries and requests.
  • Ability to work independently and to collaborate in a team setting.
  • Ability to deal with uncertainty and adapt to changing priorities.
  • Pragmatic, proactive, and goal-oriented.
  • Ability to project and maintain a professional and positive attitude.

Working Conditions

• Travel: 0-5%
• Lifting: 0-10 lbs.
• Other: Computer work for long periods of time.

Note: This job description should not be deemed all-inclusive. Additional requirements and expectations may be assigned. Employees are expected at all times to adhere to company policies and company SOPs.

EEO Statement

Clario is an equal opportunity employer. Clario evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, or disability.