Project Manager / Coordinator

  • location: Butler, NJ
  • type: Permanent
  • salary: $65,000 - $80,000 per year
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job description

Project Manager / Coordinator

job summary:
The incumbent oversees the planning, implementation, and tracking of individual client projects which have beginning, ending and specified deliverables.

This position requires strong organizational, oral and written communication skills. The incumbent must be familiar with drug development, GCP, GLP and GMP concepts as they apply to compliance auditing and consulting, client relations, and sufficient knowledge to work with internal staff on strategic and operational initiatives. The incumbent must be able to use business office software in an advanced way including Word, Excel, Access, Microsoft Project, PowerPoint, SharePoint, and MS Planner.

location: Butler, New Jersey
job type: Permanent
salary: $65,000 - 80,000 per year
work hours: 9 to 5
education: Bachelors
  • Achieve project objectives by working with team members to set project priorities and milestones and resolve project conflicts
  • Develop, track, and appropriate notify of parties of project timelines and quality metrics
  • Work with finance department, as needed, to ensure correct invoicing each month
  • Manage auditing projects from conception through final audit report completion/CAPA resolution and other types of projects.
  • Proactively identify and resolve issues, and participate in process improvement initiatives as required
  • Respond promptly and appropriately to project questions and issues raised by clients, vendors, consultants, etc.
  • Perform other duties as assigned
Staff the Project:

  • Select and manage project staff and/or contractors according to the established policies and practices of the organization
  • Ensure that contractor files are properly maintained and kept confidential
  • Ensure that all project personnel (i.e., auditors) receive an appropriate orientation to the organization, the project, and related procedures
  • Work with the administrative assistant to identify additional qualified consultants to work on the project as appropriate
Oversee the Project:

  • Oversee staff on the project to ensure it is executed according to the LOI and track for deliverables
  • Solicit forms, records and other documentation from clients as required for audit preparation and implementation
  • Ensure that auditors have the proper SOPs on an ongoing basis
  • Ensure forms and records to document project activities are completed and properly stored
  • Set up files to ensure that all project information is appropriately documented and secured
  • Monitor the progress of the project and make adjustments as necessary to ensure the successful completion of the project
  • Participate in weekly sessions to update stakeholders including appropriate staff in the organization and clients on the progress of the project, if applicable
  • Review the quality of the work completed with the project team on a regular basis to ensure that it meets the project standards
  • Write weekly tracker report commentary and collaborate with office administrative assistant to deliver weekly reports during the first business day of each week to internal management and to clients
  • Collaborate with internal team to ensure projects are delivered in a compliant and timely manner
  • Communicate with clients as per project requirements; leverage escalation, where appropriate
  • While in process, assess whether the project deliverables are on time and at the required level of quality
  • Evaluate the outcomes of the project as established during the planning phase via the Access database and MS Project or other applicable Project Management software/databases
  • Bachelor's Degree is a Scientific Discipline, Biology Preferred
  • 3-5 years planning and/or project management experience
  • 1-3 years direct experience/knowledge of GxP auditing and consulting
  • Experience communicating with multiple external parties
  • Knowledge of project management, corresponding software to track workflow, and of the compliance auditing process
Proficiency in the use of computers for:

- Word processing

- Data base management and metric development

- Spreadsheets

- E-mail

- Internet

skills: CRF, Clinical research, GLP (Good Laboratory Practice), CRFs, Clinical Data Management, GCP (Good Clinical Practice), CTMS (Clinical Trial Management Systems), RMV (Routine Monitoring Visit)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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