gcso innovation lead - 8644.

• A minimum of 5 years of experience implementing complex initiatives within a regulated matrix / partnership environment within the Pharmaceutical, Biotechnology, and/or CRO industry
• Proven track record of successfully leading cross-functional projects in a global environment
• Previous team leadership or line management experience is preferred
• Good working knowledge of GCP guidelines in different regions

Job summary:

The primary function of this position is responsible for identifying and exploring opportunities that improve clinical studies to be patient centric and preparing for the implementation of scalable solutions working in partnership with internal and external stakeholders.  The geographical scope is global.

Major accountabilities:

As the GCSO Innovation Lead:

• Develop the framework and processes (including best practices) needed to successfully implement selected initiatives and programs by capitalizing on partner’s experience to contribute to the Clinical Development Plans via Program Delivery Leads and Clinical Program Directors
• Manage the GCSO Initiative Portfolio Management to define and prioritize GCSO initiatives including monitoring and tracking the status of all GCSO implementation projects to deliver according to project timelines
• Conduct frequent and timely communication of project progress to all stakeholders and ensure alignment of goals
• Lead “Current State and Future state” assessments around capabilities and/or processes from ideation and exploration to determine business improvement areas in partnership with internal stakeholders
• Prepare the organization for the change management on new initiatives in clinical studies and create an awareness campaign to support the implementation
• Identify, gain alignment on, and drive the piloting of specialized vendors needed to execute DevMed IT and New Development Paradigm Strategy and provide light touch support for the implementation ensuring processes and SOPs have been updated accordingly
• Build external networks of peers and providers to ensure is at the forefront of new technologies and initiatives regarding clinical study innovation and participate on external work groups (e.g. Transcelerate, IMI, etc.) 
• Educate & collaborate with Development /Medical Patient Value Practice and other key stakeholders on knowledge sharing and inform on GCSO innovative solutions
• Work with strategic partners to ensure alignment on systems and processes for implementing new vendors or capabilities
• Build and ensure a high level of internal collaboration and alignment across key stakeholders, as well as with Strategic Partners 
• Ensure best industry practices and high-quality deliverables consistent with all applicable guidelines and regulations

As a member of the GCSO Innovation team:

• Participate in the leadership meetings by advising and supporting the Head of GCSO Innovation in management of strategic and operational issues related to GCSO Innovation team and GCSO 
• Collaborate on daily basis with GCSO Innovation team, GCSO, PVUs, IT, and other relevant interfaces, including strategic partners, to ensure integration of activities and identification of areas for improvement
• Develop clearly defined strategies and lead or contribute to assigned global, cross-functional interdisciplinary, high priority initiatives and process improvements
• Collaborate across Development / Medical Patient Value Practice, GCSO, PDL, CPM, IT, and relevant business units and maintain effective working relationships with interfacing groups
• Support efficient and effective communication and information exchange across Development / Medical Patient Value Practice, GCSO, IT, and other stakeholders
• Support activities that provide operational structure for GCPM such as:

1. Budget planning and management 
2. Resource planning and management
3. Policy and procedures development and maintenance
4. SOP review and update activities
5. Knowledge management and training

• Mentor and train personnel in accordance with their background, skills and experience
• Ensure that all SOPs are adhered to and country regulations and GCP guidelines are followed with respect to site selection and engagement
• Travel as required

Consultancy

We offer an attractive salary with extra-legal advantages: 

• Group insurance
• Hospitalisation insurance
• Meal vouchers of 7 euros gross per working day
• Reimbursement km or company car 
• Monthly allowance (80 euros net per month)
• A 13th month
• Training
• Etc

A rate as freelance is also possible