Job Summary

The Project Management Associate will support the Project Manager (PM) or Program Director (PD) to ensure that contracted services for full/multiple-service clinical research projects (Contract Research Organization [CRO] model) and/or Functional Service Provider (FSP) programs with functional delivery components are carried out as required. The Project Management Associate will help support the Project Manager or Program Director to oversee the activities and deliverables of project and/or program team members to ensure that efficient and effective management of their assigned clinical research project and/or program. The Project Management Associate may be assigned to multiple projects and must be able to work independently as well as in a team environment. The Project Management Associate may act as primary resource and point of communication for the client and project team when the Project Manager or Program Director is unavailable.

Essential Duties & Responsibilities

• Supports Project Manager or Program Director in the overall oversight, coordination and management of projects and/or programs from start-up to closeout, to ensure deliverables/execution within the contractual timelines.
• Participate in team, client, and cross functional meetings.
• Assist the Project Manager or Program Director in project and/or program specific financial management, including but not limited to, contract adherence, budget management and regular budget reviews with the client.
• Assist the Project Manager or Program Director in providing and/or ensuring completion of appropriate project or program training for the clinical research staff.
• Assist with the generation of a comprehensive and detailed study-specific Project Plan (including review of underlying functional plans to ensure alignment) and/or Program Plan
• Assist with the creation and maintenance of documentation for given clinical studies including but not limited to training materials, pharmacy and other binders, project plans, presentations, reports, and Governance board meeting slides.
• Assist the Project Manager or Program Director in establishing and managing processes to track and analyze critical project or program information & metrics, including but not limited to, timeline management, project projections and forecasts, and trend and gap analyses.
• Under the supervision of the PM or PD, assist with maintenance of tracking tools of clinical studies. Produces reports from tracking systems as required.
• Follow applicable Standard Operation Procedures (SOPs).
• Ensure compliance with applicable GCPs through training, processes, and early issue identification and correction.
• May manage project or program vendors to ensure quality deliverables within expected quality, timelines and budget
• Serve as back-up to the PM or PD on assigned studies.
• Other duties, as requested by management
• Travel, up to approximately 10%

Qualifications

• Education: Bachelor’s degree, preferably in a scientific discipline or equivalent combination of education and experience.

• Certification: None required

• Experience: At least 3 years of experience in clinical research

• Other Requirements

  • Excellent interpersonal and organizational skills with attention to detail.
  • Strong computer proficiency in MS Office including Outlook, Word, Excel, and PowerPoint.
  • Ability to work well in a high-paced team environment but also independently without significant oversight.
  • Flexibility in work hours and ability to travel.
  • Must be fluent in English Language.
  • Must possess or be able to obtain a current passport or identity card as applicable.

This job description is a summary. It is not intended to be comprehensive in detail. Individuals with this job title will be expected to perform according to their individual goals and evaluations in addition to this job description and all applicable standards (SOPs, manuals, code of conduct, laws, regulations, etc.).