Are you a Senior Project manager with min 6 years experience in Global Clinical Research?
Are you fluent in English and in Dutch?
Are you available for an hybrid work (combination of remote work and on-site work in Belgium)
Then check out this exciting project within clinical innovation at a global health care company. Don't hesitate and apply!
The Client's Clinical Innovation department reports into Global Development and is dedicated to driving innovation into the clinical operating model to make clinical development faster and better for patients, investigators, Client, and the industry at large. The approach is to learn through doing: they design and conduct demonstration projects that generate knowledge about novel operational models and methods.
These projects identify and test novel approaches, processes, technologies and best practices that have the potential to reduce trial set up and execution cycle times, and/or reduce cost; generate conclusive results to make the business case for scale-up or adoption of new capabilities or approaches. These projects are executed in close collaboration with both internal and external stakeholders and can also be in collaboration with public/private partnerships. Their success come by way of their entrepreneurial culture and teamwork.
The Clinical Innovation Project Managers support several transformational demonstration projects, in collaboration with internal and external stakeholders, in areas such as digital health, patient & site centricity, nonconventional trial methods, real-world evidence and data sciences. These projects will identify and test novel approaches, processes, technologies and best practices that have the potential to reduce trial set up and execution cycle times, and/or reduce cost; generate conclusive results to make the business case for scale-up or adoption of these new methods.
Our Client is currently looking for a Senior Project Manager for an innovation project in federated machine learning, combining omics and non-omics data in multiple myeloma and bladder cancer. The Senior Project Manager will manage all aspects of this project, including the maintenance and monitoring of the project management plan, with all aspects of resourcing, communication and change management.
The project will enter its final phase (year 3) and sustainability planning will play a critical role. The Project Manager should have prior project management experience in a clinical setting, ideally experience and leadership in projects where real world data or novel types of patient level data (data from electronic medical records, genomics and/or imaging data) have been re-used for clinical research applying privacy-preserving methods.
Experience and knowledge regarding legal and ethical committee requirements would be required for the project management of these innovative clinical research initiatives. The Senior Project Manager will be coordinating a dynamic and diverse public private partnership consortium.
- Defining the overall project strategy for year 3 of the project together with the project coordinators and WP leaders and assure the strategic goals are reflected in the project management plan and all actions to accomplish this plan (incl. facilitating steering committee and cross-WP meetings).
- Ensuring timely and accurate documentation and communication of progress and issue escalation. Day to day monitoring of the project management plan and making adjustments as needed, in close alignment with the work package leaders and the project coordinators. Leading activities of ongoing review of progress on deliverables, completion of milestones and risk analysis and mitigation.
- Monitoring project budget and supervising actuals vs forecast expenses, and reviewing assigned vendor invoices/spend.
- Managing the identified KPIs to measure outcomes and success for the project, ensuring all partners are aligned on the approach to reach these KPIs. Monitoring risk and mitigation planning which may lead to a deviation of certain KPIs.
- Providing leadership and project management for the emerging sustainability initiatives which have to create mid and long-term value for each of the consortium partners. Support the consortium in identifying these most appropriate sustainability projects and helping to build the Return-on-Investment case and business plan for the sustainability phase.
- Leading the communication, including supporting internal and external dissemination activities in order to ensure value generation for all consortium partners.
- Successful project close out, assuring all administrative and financial requirements are fulfilled and making the project and its deliverables audit ready.
- An advanced biomedical sciences degree is preferred (Master's/PhD/PharmD degree) with a minimum of 10 or more years of total business experience is required.
- A minimum of 6 years of project management experience in global clinical research either in a CRO, Pharma, consultancy or other clinical trial sponsor environment is preferred.
- Proven experience in managing and executing complex projects from start to finish.
- Fluent in Dutch and in English
- Excellent organizational, project management and influential management skills, complemented by a "hands-on" operational and business planning orientation is required. PMI (or equivalent) certified.
- Experience leading public private partnerships / consortium projects.
- Familiarity with and interest in health technology and health information technologies is required; direct experience with health information technology, healthcare technology, and mobile health applications is highly preferred.
- Experience with real-world evidence and data sciences is preferred.
- Experience contributing to innovative analytical solutions is preferred.
- Experience with management and supervision of vendors is preferred.
- A self -starter with strong results orientation, who can operate independently and can navigate complex, matrixed environments is required.
- Outstanding communications skills, both written and oral, capable of effectively summarize abstract concepts into clear, concise and insightful business cases.
- Experience collaborating successfully with global clinical teams, R&D Operations, Therapeutic
- Areas and Medical Affairs is preferred.
- Strong team player, motivating professional colleagues and stakeholders cross functionally and across organizations within the consortium.
- Availability for hybrid work (combination of remote work and on-site work in Belgium)
- Existing right to work in Europe required
- A balanced salary package based on your capabilities and experience