Job Description

Employment Type: Full-time

Position Overview

This role provides essential administrative and operational support to Clinical Project Managers, contributing to the successful execution and close-out of clinical trial projects. The position involves detailed document management, communication facilitation, and proactive issue resolution to ensure project timelines and quality standards are met.

Responsibilities

Project Administration and Support:

• Assist Clinical Project Managers (CPMs) with project administration.
• Develop project-related documents.
• Review and edit project presentations.
• Participate in project meetings, conference calls, and training calls.
• Read and understand project protocol documents.
• Act as a liaison with cross-functional team members to ensure timely completion of study deliverables.
• Report study needs and issues.
• Support overall project start-up, execution, and close-out activities.
• Support project finance-related activities, including:
  • 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 and Communication:

• Assist CPMs in maintaining, reviewing, and communicating project progress.
• Monitor internal data flow to ensure task completion within agreed-upon timeframes.
• Respond to inquiries professionally, courteously, and in a timely manner.
• Communicate with clients regarding project status.
• Verify protocol imaging requirements are met and queries are appropriately identified.
• Serve as acting Project Manager in the absence of the assigned Project Manager.
• Create, review, and distribute project reports internally and/or externally.

Timeline Management and Client Interaction:

• Ensure the development and adherence to project timelines.
• Follow up on outstanding items, including missing data, incomplete paperwork, and queries.
• Assist in tracking and resolving client issues.
• Serve as an additional point of contact for clients, sites, sponsors, etc.
• Support logistics with the distribution, management, and tracking of site-facing materials.
• Keep CPMs and supervisors advised of current issues.

Quality Service and Departmental Standards:

• Read, understand, and adhere to organizational Standard Operating Procedures (SOPs).
• Execute technical and clinical functions as required by the study protocol in accordance with Clario's GCPs, ICH, and FDA Guidelines.
• Review and provide recommendations to management on operational procedures.
• Participate in process improvement initiatives.

Secondary Responsibilities:

• Contribute to team effort by helping internal and external customers achieve results.
• Attend project-specific, system, and team-focused trainings.
• Perform other duties as assigned.
• Maintain 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 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 is not intended to be 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, disability/handicap status, or any other characteristic protected by law.