Beschreibung
For our Pharma client we are currently looking for a GCSO Innovation Manager (m/f/d)Start: 17.01.2022
End: 31.12.2022
Volume: Fulltime
Location: Remote
Background
Responsible for identifying and exploring new innovative solutions that could be implemented in clinical studies to be patient centric and supporting digital transformation projects by preparing for the implementation of scalable solutions working in partnership with internal/ external stakeholders. Global scope.
Tasks:
* Evaluate and assess new solutions (incl. digital) to be embedded in clinical studies incl. but not limited to telemedicine, wearables/devices/sensors, eConsent, eCOA, and others to be implemented during the study concept design
* Develop the framework and processes (+ best practices) needed to successfully implement selected digital transformation solutions in clinical studies and provide the continuous support (light touch) throughout the study until closeout
* Collect surveys related to the use of new solutions and lessons learnt
* Conduct frequent and timely communication of project progress to all stakeholders and ensure alignment of goals
* Change management on new initiatives in clinical studies and create an awareness campaign to support the implementation
* Support GCSO Innovation Leads on Digital Transformation projects and implement/pilot new solutions
* Build external networks of peers and providers to ensure UCB 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 Solutions, Patient Value Practice and other key stakeholders on knowledge sharing and inform on GCSO innovative solutions
* Work closely with strategic partners to create collaboration
* Ensure best industry practices
* Collaborate across Development / Medical Patient Value Practice, GCSO, PDL, CPM, IT, and relevant business units and maintain effective working relationships with interfacing groups
* Support activities that provide operational structure for GCPM and PDL such as:
o Budget planning and management
o Resource planning and management
o Policy and procedures development and maintenance
o SOP review and update activities
o Knowledge management and training
* Ensure that all UCB SOPs are adhered to and country regulations and GCP guidelines are followed with respect to site selection and engagement
* Collaborate with CSA to manage the scale up of the new technological solutions transitioning to UCB Enterprise, includes region/country implementation, testing, UCB support (if any), systems integration, product/system lifecycle
* Align with ADL/SDL/CDS and provide input to processes on data standards and acquisition for new digital solutions
* Align with RML on protocol complexity to prioritise, explore, and implement digital and/or remote assessment including primary and secondary endpoints
* Travel as required
Skills:
-min 2 yrs exp implementing complex initiatives within a regulated matrix / partnership environment within the Pharmaceutical, Biotechnology, and/or CRO industry.
- 3yrs Project Management
Michael Bailey International is acting as an Employment Business in relation to this vacancy.