PV Project Director

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🕒 vor 23 Tagen

🌲 North Carolina – Remote

🌲 North Carolina – Remote

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ERGOMED

WebsiteLinkedInAlle Stellen

1001 - 5000 Mitarbeiter

Gegründet 1997

🧬 Biotechnologie

💊 Pharmazie

⚕️ Krankenversicherung

Biotechnology • Pharmaceuticals • Healthcare Insurance

ERGOMED ist eine weltweit tätige Unternehmensgruppe, die spezialisierte Dienstleistungen für die Biotechnologie- und Pharmaindustrie erbringt. Sie ist in verschiedenen Geschäftsbereichen aktiv, darunter Ergomed Clinical Research, PrimeVigilance und ADAMAS Consulting, und bietet als Clinical Research Organization (CRO) umfassende Full-Service-Fähigkeiten. Mit Fokus auf Onkologie, seltene Erkrankungen und komplexe Studien bietet Ergomed zudem End-to-End-Pharmakovigilanz- und Medical-Information-Services sowie umfassende GxP-Audits. Ergomed unterstützt die Arzneimittelentwicklung mit einer globalen Präsenz in rund 100 Ländern.

Beschreibung

• 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 • Being involved in tasks to be delivered to the client, as applicable • 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.

🎯 Anforderungen

• 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)

🏖️ Vorteile

• 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