Scope of activities:
– Global Clinical Project Manager
– Primary Purpose
– Home-based
– total working hours
„The Global Clinical Project Manager (GCPM) is critical to the successful conduct of Biopharmaceutical-sponsored clinical trials as a matrix leader of the core project team. The GCPM is responsible for the successful delivery of a Biopharmaceutical project(s) from the development of the RFP including study budget, proposed staffing and timelines. The GCPM will be client-facing and serve as the internal lead of the project through the life cycle of the study, ensuring effective project delivery in agreement with contracted project timeline and budget. The GCPM directs project delivery by driving team and financial efficiency, work product quality, and is responsible for client satisfaction through strong relationship management.
Responsibilities
• Serves as a primary lead for major project bids and multi trial initiatives
• Leads development of RFPs for biopharma clients, identifying appropriate staff, preparing proposal language, and developing budget and timelines in collaboration with leaders and key subject matter experts (SMEs).
• Ensures that deliverables for the assigned project/s are completed according to the contract budget, schedule, and quality standards. Projects will be effectively managed in all areas of performance.
• Develops successful working relationships with clients, executive management, and project staff and collaborate to manage project issues, proactively identify and mitigate risks and drive milestone achievement.
• Serves as the primary point of contact for biopharma clients and demonstrate proficiency in knowledge and understanding of client needs.
• Tracks project deliverables against contract using Emmes’ tools. Proactively prepare/present study metrics to maintain transparency for internal/external stakeholders. Monitor trends and drive changes to the plan as needed; identify risks to delivery and agree mitigation plans with the project team to be presented to the client.
• Ensures adherence to quality control expectations and milestone timelines for delivery of contractually required reports and deliverables.
• Oversees all project resources (i.e., budget, personnel, and subcontracts).
• Support the culture of the business unit according to Emmes core values.
• Identifies and manage changes to scope and requests for out-of-scope activities. Collaborate with Business Development, Contracts Department, and executive management to ensure timely execution of contract amendments/change orders. Prospectively manage client expectations.
• Presents in bid defense meetings in collaboration with Business Development.
• Develops study management plans in collaboration with Clinical Study Manager (CSM)/Clinical Team Lead (CTL), Clinical Research Manager (CRA) and other core team members.
• Identifies and documents lessons learned from study successes and challenges to promote development of best practices.
• Models and propagates Emmes’ commitment to a culture of quality in all aspects of our deliverables, utilizing a solution-based, science-driven, value-added approach in collaborating with clients.
• Supports internal stakeholders on departmental initiatives upon request.
• Foster a global perspective amongst the project teams from a depth of understanding of the interdependences of project, teams and timelines.
• Ability to delegate tasks according to individual/team strengths within the global project team.
• May supervise GCPM team members
• Provides leadership for the GCPM team through mentoring, guiding, and coaching
• Supports recruitment/retention strategy and related initiatives
• Assesses direct reports training needs
• Approves timesheets, expense reports, and leave requests
• Collaboratively conducts performance and compensation review activities with the applicable project leader or designee
• Responsible for addressing employee relations issues and resolving problems
• Other duties as assigned.”
Employer:
– Emmes/Neox s.r.o.
– 2040 Budaörs Puskás Tivadar út 5.
– Dr. Péntek-Szász Zsuzsanna
– zsuzsanna.pentek@neoxcro.com
– 06704160200
Targeted labour:
– resident, professional
– English
Fees:
fixed salary
End of application:
2021-12-31
Required attachements:
CV, diploma
Other:
Experience
• Bachelor’s degree in a scientific discipline
• Minimum 12 years demonstrating scientific principles appropriate in managing a clinical research portfolio, including multi-phase research experience in a broad range of phases and client types
o At least 8 years would be working in a pharmaceutical and/or CRO setting, serving in a global Clinical Trial Team Lead or GCPM role or equivalent position
o At least 3 years supervisory experience in a similar work environment
• Demonstrable track-record of success delivering complex/ high priority clinical trials within agreed time, quality and cost working across multiple therapeutic areas, phases 1-3, in a global capacity
• Demonstrated experience in developing and fostering strong client and internal relationships
• Thorough understanding of ICH GCP and all applicable global regulatory regulations and guidelines
• Skilled in MS Office Suite of products and working knowledge of Clinical Trial Management Systems, electronic Trial Master File, and electronic Data Capture systems and solutions
• Demonstrated experience in managing diverse staff and leading successful teams with direct and indirect supervision responsibilities
• Additional project management certifications and training are an asset