Our client is a leading global player in the pharmaceutical industry with global headquarters in Basel, Switzerland. They are undergoing a transformation with respect to culture and outside perception. The organisation focusses on novel therapies in oncology and ophthalmology and is also currently developing a world-leading pipeline in neuroscience and dermatology with one of the strongest pipelines of phase II/III studies in the world.
We are currently looking for a Digital Solutions Manager to be based in Basel for a contract position.
As a Digital Solutions Manager you will collaboratively drive the implementation of digital solutions in clinical trials and provide the highest level of support to clinical trial teams. You will hold 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.
- 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;
- 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.
Qualifications and Experience:
- Relevant working/residency permit or swiss/EU-citizenship required;
- Graduate degree or equivalent in life sciences or computer science, engineering fields;
- 4+ years of experience in life science/healthcare including experience in clinical research;
- 4+ years of experience managing complex innovation-related projects;
- Direct experience with digital health or other patient facing clinical trial technologies required;
- Strong understanding of all aspects of clinical drug development with particular emphasis on clinical trial design and trial execution;
- Knowledge of regulatory requirements around digital health technologies in clinical trials preferred;
- Successful track record of problem-solving and navigating uncharted territory without clear precedent;
- Advanced project/program management skills,
- Experience in vendor engagement and collaboration;
- Strength demonstrated in strategic decision making, scenario evaluation, change management and contingency planning;
- Experience presenting/speaking to with a proven track record of effectively communicating complex initiatives;
- Fluent in English (written and oral).