About This Simulation
Your Role
Senior Manager of Clinical Affairs at
Sentec
Your Goal
Your Mission
In this AI Simulation you will take the role of a Senior Manager of Clinical Affairs dealing with a complex clinical trial that is impacted by several factors.
Simulation Details
Sentec is a Swiss-American medical device company specializing in respiratory care, founded in 1999 by Dr. Hans Müller. The company is known for its advanced technologies like the TCM5 FLEX monitor and the V-Sign™ sensor, which provide non-invasive, continuous monitoring and effective therapeutic solutions for respiratory patients. Sentec conducts around 20 clinical trials annually with an 85% success rate, focusing on areas such as COPD, sleep apnea, and neonatal care. The company holds a 25% market share in the global respiratory care market, with significant achievements including the 2022 MedTech Breakthrough Award for “Best Respiratory Monitoring Solution” and strategic partnerships with leading healthcare institutions.
The main challenge in this simulation is to successfully launch a groundbreaking clinical trial for Sentec’s novel respiratory monitoring device, the V-Sign™ sensor. This trial must navigate the stringent requirements of the EU Medical Device Regulation (MDR) and manage internal resource constraints, including a limited budget and staffing shortages. Additionally, Sentec faces intense competition from MedTech Innovations, which has recently launched a rival device. The player must ensure compliance, manage internal stakeholder relations, and strategically plan and execute the trial to maintain Sentec’s competitive edge.
In this simulation, you will take on the role of the Senior Manager of Clinical Affairs at Sentec. Your primary responsibility is to oversee the launch of a complex clinical trial for the V-Sign™ sensor. You will interact with key team members and stakeholders within the company, including Dr. Anika Meier, the Lead Clinical Researcher, and Marco Rossi, the Head of Resource Management. Your tasks include addressing internal policy changes impacting the trial and optimizing internal resource allocation to manage constraints and competition. Each decision you make will directly impact the project’s progress and outcome, requiring careful consideration and strategic thinking.
– Collaborate with Dr. Anika Meier to discuss the implications of new internal policies and identify necessary adjustments to the trial plan.
– Ensure the trial design meets all regulatory requirements.
– Negotiate with Marco Rossi to secure the necessary resources and support for the trial.
– Develop and implement a strategic plan that optimizes resource allocation and addresses competition from rival companies.
– Maintain clear communication with key internal stakeholders, providing timely updates and addressing concerns promptly.
Team
Who you will work with in this Simulation
Your team is 100% generated by AI – you will not interact with real people and no human will read your conversation.
Lead Clinical Researcher
Head of Resource Management
Director of Clinical Affairs
Organization
A Swiss-American medical device company specializing in respiratory care.
Helpful for
Senior Manager of Clinical Affairs, Clinical Research Coordinator, Regulatory Affairs Specialist
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