ERGOMED

PV Project Director

ERGOMED

full-time

Posted on:

Location Type: Remote

Location: United States

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Job Level

Lead

About the role

  • Management and support of a team of Project Managers
  • Ensuring that all contracted activities performed on behalf of PrimeVigilance clients are delivered within budget and are on time with good quality and in compliance with the applicable regulatory requirements
  • Support project teams as PV expert on all contracted activities performed on behalf of PrimeVigilance clients, as necessary
  • Providing support to Business Unit Leads, Head of Global PM department and senior leadership management, as applicable, in other activities undertaken on behalf of the client and the company
  • Together with direct reports representing the client's and PrimeVigilance interests with the aim of keeping the agreed project scope
  • Oversee management of changes to the project scope, project schedule and project costs, as applicable
  • Maintaining good client relations and ensuring a consistently high quality of work for each client
  • Being involved in issue escalation process, as applicable
  • Understand client PV requirements and ensure service provided addresses all requirements
  • Overseeing and monitoring Project set-up and maintenance activities planning; attending client meetings, as required
  • Having an overview of deliverables to the clients
  • Oversight on all issues communication with clients
  • Overseeing training of project teams
  • Close cooperation with other PrimeVigilance and/or the client’s respective departments making sure contracted activities are delivered with high quality and within set timelines
  • Assurance that all Primevigilance departments and respective personnel are familiar with the client and the project scope
  • Review of client specific core documents (e.g. Joint operational guidelines, Safety management plan), as applicable
  • Making sure invoices are prepared and sent on time
  • Review project specific analysis, as needed
  • Advising the client as requested or as appropriate in PV matters such as changes in regulations/guidance
  • Providing the client with appropriate qualified resources to ensure their project is managed and handled effectively
  • Overseeing the management of Quality Management System activities for the client, as required
  • Making sure that quality standards applicable to the respective client are met
  • Ensuring compliance with worldwide PV regulatory obligations; manage the process for Quality Events (QEs) and implement corrective and preventative action (CAPA)
  • Participation in client audits and inspections
  • Accountable for performance development and career management of Project Managers
  • Manage performance and growth opportunities of Project Managers
  • Provide soft skill and technical skill development to grow the PM team talent
  • Develop career plan and provide coaching and mentoring
  • Communicate regularly with Project Managers to ensure their knowledge, understanding, and compliance with assigned project goals and departmental and corporate strategies and objectives
  • Support Business Development by assisting with resource planning
  • Engaging and coordinating with other line managers across the Project Management department
  • Participate with the PrimeVigilance Senior Leadership Team to determine and operationalize corporate strategies and visions for the continued growth of PrimeVigilance
  • Participate to the development and implementation of recruiting, interviewing, and hiring strategies
  • Conduct new employee orientation and onboarding
  • Participate in project review meetings with senior management to ensure areas of development, training needs and coaching are aligned with the business needs
  • Monitor and/or manage assigned studies as needed according to all applicable SOPs, regulations, and guidelines
  • Assess Project Managers performance and liaise with Director of Projects where required
  • Assist project teams with coordination of study activities to ensure project deliverables meet sponsor deadlines and ensure all objectives and expectations are fulfilled
  • Work with all operational units to help investigate issues and promote effective resolutions
  • Establish strong professional relationships with colleagues by building trust, open communication, and managing day-to-day operational issues
  • Provide excellent customer service to both internal and external clients; ensure the same from the Project Managers
  • Review and approve weekly timesheets for PrimeVigilance tasks
  • Review and approve requests from PMs for time off and support Project Management coverage plan

Requirements

  • Life science graduate, pharmacy, nursing or other healthcare-related qualification
  • 5 years of appropriate work experience
  • Excellent client-facing and internal communication (written and verbal) skills
  • Organization skills, including attention to detail and multitasking
  • Management skills, including time and issue management
  • Conflict resolution skills
  • Decision making
  • Team working
  • Ability to motivate/coach people; leadership
  • English - fluent (spoken, written)
  • Advanced literacy (MS Office)
Benefits
  • Training and career development opportunities internally
  • Strong emphasis on personal and professional growth
  • Friendly, supportive working environment
  • Opportunity to work with colleagues based all over the world, with English as the company language
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
project managementquality management systemregulatory complianceperformance developmentresource planningSOPsCAPAclient auditsissue managementmultitasking
Soft Skills
client-facing communicationinternal communicationorganizationconflict resolutiondecision makingteamworkleadershipcoachingattention to detailmotivation