Digital Solutions Manager
- Contract
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For our client in Basel we are looking for Digital Solutions Manager to fill the 6 months contract.
Job title: Digital Solutions Manager - Patient Centric Remote Trial (PCRT)
Location: Basel
Duration: 01.09.2020 - 28.02.2021
Workload: 100%
Purpose:
The Digital Solutions Manager will collaboratively drive the implementation of digital solutions in clinical trials and provide the highest level of support to clinical trial teams. The Digital Solutions Manager is a core team member of the Patient Centric Remote Trial (PCRT) program, holds direct responsibility to manage implementation of digital solutions and enabling services in clinical trials and will coordinate with multiple internal and external stakeholders and vendors as required. This requires the ability to influence and lead multi-disciplinary teams across a variety of subject matters with minimal authority to deliver with high quality and in accordance with approved strategy.
Specific responsibilities in this role include:
• Responsible for the day-to-day delivery of PCRT solution implementation in clinical trials to the satisfaction of internal customers
• Independently drive implementation of proposed digital solutions and enabling services per agreed strategy, budget and timelines
• Accountable for development and/or authoring of all documentation associated with PCRT implementation with input from vendors, subject matter experts and internal customers (operational plans, risk assessments, quality plans etc.)
• Take accountability to ensure adherence with internal policies and procedures (e.g. compliance, QA, etc.)
• Provide highest level of support to clinical trial teams implementing PCRT
• As needed, contribute to PCRT program strategy by taking on ad hoc tasks to support the Digital Program Head and Digital Solution Director
• As needed, lead one or more PCRT workstreams, including the development and maintenance of project charters, requirements documents, timelines, and financial forecasts
• As needed, support digital solution evaluations and engagement with external partners
• As needed, develop, design and execute pilot programs, to evaluate value of digital solutions
Major Accountabilities:
• Lead cross-functional project teams and multidisciplinary experts with varying levels of technological proficiency to ensure successful implementation of digital solutions
• Develop and maintain operational plans, risk assessments, quality plans, project charters, timelines, and financial forecasts
• Ensure delivery of digital solutions to cost, time and quality standards
• Develop and manage new processes or best practices where no process or precedent exists, while maintaining compliance with current regulations (both internal and external)
• Proactively manage risk, including assessment of impact on clinical operations and development of mitigation plans
• Communicates program progress/issues horizontally and vertically in an open and timely manner
Education:
Graduate degree or equivalent in life sciences or computer science, engineering fields
Languages: Fluent English written and oral
Experience:
1. 4+ years of experience in life science/healthcare including experience in clinical research
2. 4+ years of experience managing complex innovation-related projects
3. Direct experience with digital health or other patient facing clinical trial technologies required
4. Strong understanding of all aspects of clinical drug development with particular emphasis on clinical trial design and trial execution, highly preferred
5. Knowledge of regulatory requirements around digital health technologies in clinical trials preferred
6. Successful track record of problem-solving and navigating uncharted territory without clear precedent
7. Advanced project/program management skills
8. Experience in vendor engagement and collaboration
9. Strength demonstrated in strategic decision making, scenario evaluation, change management and contingency planning
10. Experience presenting/speaking to with a proven track record of effectively communicating complex initiatives